Medical Products in Silicone

Transcription

1 Medical Products in Silicone 1

2 2 Medical Products in Silicone Introduction 3 Urology Catheters with Standard 4 Catheters with Integrated 5 Surgery Wound Drains &Reservoirs 6 Closed Wound Drainage Systems 8 Passive Wound Drainage Systems 9 Enteral Feeding GastrostomyTubes 10 NG-Tubes 10 Vascular Accessories Identi Loops TM 10 Silclamps TM 10 Tubing 11 OEM Services 11

3 Trust in Professionalism &Excellence Degania Silicone has over 20 years of experience in the developmentand production of silicone products. Sincethe companywas founded in early 1984,we have concentratedon themedicalsector.todaywehave valuable experience and excellentclean-room production facilities which enable us to provide high quality and speedy solutions. The latest production technology, together withour highly qualifiedstaff, provide outstanding all-round servicewith high quality standards which areappreciated by our customers throughout the world. Finished Products -Our Role Formanyyears,Degania Silicone has offeredacomplete rangeofmedical products in silicone thatfulfill the market needs. We are a manufacturer,whoseexpertiseandfocusareconcentratedon the production of silicone products and components. Therefore, we closely cooperate with partners,who distribute our products worldwide.our sales effortsare focused on serving distributors and medical device manufacturers. We do not sell to end users. Besides our standard products we also offer contract development and production. Formoreinformation see page11ofour brochure Complete Solutions in Silicone. ComprehensiveService Degania Silicone provides comprehensive service for its distributors. We offer tailored solutions forthe individual needs of our partners: Packaging configuration:we offerthe products in various configurations, from bulk non-sterile (BNS) up to final packaging and sterile -ready to sell. Labelling: Privatelabel fulfils the corporateidentity requirements of our distributors,both on the productitself and on various parts of the packaging.wealso deliver products under the Degania-label if private label is not offered. CE-Mark: Our products arece-marked, Degania Silicone is the manufacturer according to MDD.Wealso assist our partners with appropriate documentation in obtaining their CE-mark. Outstanding quality In everything we do -from engineering to the final inspection of the finished product- our quality managementsystem meets the high levelofresponsibility essential in the medical sector.this philosophyisthe basis on which Degania Silicone has wonthe confidenceofcustomers from all over the world. EN /ISO 9001 EN /ISO EN /ISO CE-mark QSR /cgmp FDAregistration 3

4 Catheters with Standard Foley, 2-Way 6Fr 1,5 ml 8Fr 3ml 10 Fr 3-5ml 12-24Fr 5-10ml 14-24Fr 30ml Foley Ribbed, 2-Way 10 Fr 3-5 ml 12-24Fr 5-10ml Foley with longitudinal ribs for infection prevention Tiemann, 2-Way (Coude) 10-24Fr 5-10ml 14-24Fr 30ml Foley, 3-Way 16-24Fr 5-10ml 16 Fr 40 ml 18 Fr 50 ml 20 Fr 60 ml 22 Fr 70 ml 24 Fr 80 ml Tips Nelaton (straight) Couvelaire Dufour Mercier 4 Prefilled Syringes Content Sterile Water Sterile Water -Glycerine (9:1) Volume 10 ml 10 ml Comments Glycerine reduces the diffusion through Glycerine the reduces balloondiffusion wall and through therefore loss oss balloon ofand volume. therefore loss of volume. Prefilled Prefilled syringes syringes are available are as available kits withasskits the catheter the catheter or as stand-alone or as stand-alone sterile. sterile. ile

5 Catheters with Integrated Standard The balloon is adhered to the outer diameter of the catheter shaft, thus resulting in an increased diameter in the balloon area. Asmooth transition reduces discomfort tothe patientduring catheterization. Integrated Degania Silicone developed its Integrated balloon to ensuremorecomfortfor the patient.the balloon is integrated in the shaft, which eliminates the step between shaftand balloon. The resulting,evensurface minimizes the friction in the urethraand the discomfort tothe patient during catheterization. Foley, 2-Way(Integrated) 12 Fr 5ml 14-24Fr 5-10ml Suprapubic (Integrated ) 12 Fr 5ml 14-20Fr 5-10ml Suprapubic, Pigtail (Integrated ) 12 Fr 5ml 14-18Fr 5-10ml Nephrostomy (Integrated ) 12 Fr 5ml 14-24Fr 5-10ml t Suprapubic and nephrostomy catheters with standard balloon available on request. 5

6 Wound Drains Fluted Drains Shape Color Comments 10 Fr s 10,15&19Frfully or 3/4fluted 15 Fr transparent 24 fullyfluted 19 Fr round or Clear with blue ROPstripe, white fully ROP 24 Fr white Trocar optional 7mm 10 mm Flat Perforated Drains flat white s 7and 10 mm fullyor3/4 fluted Length Color Comments 4mm 820 mm clear Hubless 7mm 800 mm or Clear with blue ROPstripe, white fully ROP 10 mm 800 mm white Trocar optional Round Perforated Drains Length Color Comments 7Fr End perforation 10 Fr 1250mm clear Clear with blue ROPstripe 15 Fr Trocar optional 19 Fr 10 Fr Centralperforation 12 Fr Clear with blue ROPstripe 14 Fr 1067mm clear Trocar optional 16 Fr 19 Fr 10 Fr 5sideholes 12 Fr Clear with blue ROPstripe 15 Fr 18 Fr 21 Fr 500 mm clear 24 Fr 27 Fr 30 Fr 33 Fr 36 Fr 6

7 Thoracic Drains Length Color Comments 15 Fr One hole at distal location 18 Fr Both ends cut to Fr clear Clear with blue ROPstripe, white fully ROP 24 Fr 500mm or Alternatively Thoracic Drain 600/5: 28 Fr white 5side perforations,600 mm lengths, 33 Fr distal end cut to Fr Easy Flow Drains (Penrose) Length Color Comments 6mm Inner teeth ensureopen drainage 8mm 300 mm Clear with blue ROPstripe 10 mm or clear s 6, 8, 10 &12mmround, 40 mm flat 12 mm 500 mm 40 mm Other Drains Multilumen Drains: 16 lumens,clear (with blue ROPstripe) or white (fully ROP) 400 mm sterile or non-sterile in rolls of 25 M Reservoirs (Bulbs) 100 cc:non-sterile in inner packaging or sterile double packed (10 items per box) 400 cc:non-sterile in inner packaging or sterile double packed (10 items per box) 7

8 Closed Wound Drain Systems Fluted Drain or Flat Perforated Drain or Round Perforated Drain (1250 mm) + + Trocar (optional) Bulb 100 cc or Bulb 400 cc Closed wound drain systems (CWDS) reducethe incidenceofinfection and allowmobility for the patient. CWDS consists of adrain, abulb and optionally atrocar. The drain can be afluted drain, aflatperforated drain or around perforated drain. The trocar is chosen according to drain size. The bulb (reservoir) can be 100 or 400 ml. CWDS can be delivered bulk non-sterile or sterile. 8

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10 Gastrostomy and NG-Tubes Type 2-Port-G-Tube 3-Port-G-Tube 3-Port-G-Tube (US) Nasogastric Tube 12-24Fr 12-24Fr 12-24Fr 10-18Fr Identi Loops TM (Vessel Loops) size Color Comments Packaging Configurations (for all sizes) Mini Forall sizes: Sterile: 2loops (18") per pouch, Maxi red, blue, 10 pouches per box Super-Maxi yellow, white Bulk-non-sterile: 50 Mdrum Bulk-non-sterile: 50 Mroll Silclamps TM (Clamp Covers) Color Comments Packaging Configurations (for all sizes) Small Red Sterile: 2clamp covers (5") per pouch, Medium White 10 pouches per box Large Blue Bulk-non-sterile: Drums: Small =20M, Medium =10M,Large =5M 10

11 Tubing 0,5 x 1 1 x 3 1,5 x 3 2 x 4 3 x 5 3 x 6 4 x 6 4 x 7 5 x 8 5 x 9 6 x 9 6 x 10 MetricTubing (IDxODinmm) 6 x 12 7 x 10 7 x 12 7 x 13 8 x 12 8 x 14 9 x 13 9 x x x x 18 12,5 x x x x x x x x x x x x x 6.35 Inch Tubing (IDxODinmm) 4.80 x x x x x x x x x x x x22.23 The listed sizes only representpartofthe existing range. Other sizesupon request. Material quality from medical grade up to long-term implantgrade. Regular packaging metric tubing: 25 MinPE-bag. Regular Packaging inch tubing: 15 MinPE-bag. Individual packaging configurations on request. Special tubing designs on request. Your Custom-Made Product-Our OEM Services Our expertise in the production of medical silicone products provides a comprehensive standard product range.we also offer contract development and manufacturing services for OEMs. Degania Silicone serves as partner to develop and produce unique and proprietary products which are exclusively marketed by the customer. Our comprehensive range of services allows OEMs to buy everything from a single source : Engineering: From the first design steps to the manufacturing process. Precision mold-making. Silicone Technology: Extrusion, injection molding,molding &dipping. Secondary Steps: Precision cutting,coating,printing,assembly (manual &automated), purchasing and integration of other components,packaging and labeling,sterilization (EtO and Gamma) CE-marking or assistancewith appropriate documentation. Contactusfor moreinformation and ask forour brochure Complete Solutions in Silicone. 11

12 European Subsidiary: Degania Silicone Europe GmbH Stadtamhof18, D-93059Regensburg, Germany Tel: +49 (0) , Fax: +49 (0) Headquarters: Degania Silicone, Ltd. Degania Bet Israel Tel: ,Fax: USASubsidiary: Degania Silicone Inc. 14 Thurber Boulevard, Suite A, Smithfield, RI 02917, USA Tel: , Fax: site: