Identity
- Trade Name
- Tenckhoff FDA UDI
- Generic Name
- Peritoneal dialysis catheter, chronic FDA UDI
- Device Name
- Tenckhoff Chronic Peritoneal Dialysis Catheter Set Silicone Catheter With 16Fr Peel-Away Introducer Set FDA UDI
- Model / Reference
- G08982 FDA UDI
- Description
- Tenckhoff Chronic Peritoneal Dialysis Catheter Set Silicone Catheter With 16Fr Peel-Away Introducer Set FDA UDI
Identifiers
- Catalog Number
- C-TCPS-15-42-28-0-15-5 FDA UDI
- Primary DI / UDI-DI
- 00827002089822 FDA UDI
- FDA Product Code
- GBW FDA UDI
- GMDN Term
- Peritoneal dialysis catheter, chronic FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4200 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
Category: Peritoneal dialysis catheter, chronic
Tenckhoff by Cook Incorporated — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Flex-Neck® — Merit Medical Systems, Inc. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Cook Incorporated
Sources (1)
- FDA UDI 4d63ec08-abec-4b47-a9f7-7a70f418b582 36 fields · synced Jun 8, 2026