Identity
- Trade Name
- Tenckhoff FDA UDI
- Generic Name
- Peritoneal dialysis catheter, acute FDA UDI
- Device Name
- Tenckhoff Acute Peritoneal Dialysis Catheter Set Silicone Catheter With 16Fr Peel-Away Introducer Set FDA UDI
- Model / Reference
- G08995 FDA UDI
- Description
- Tenckhoff Acute Peritoneal Dialysis Catheter Set Silicone Catheter With 16Fr Peel-Away Introducer Set FDA UDI
Identifiers
- Catalog Number
- C-TAPS-15-31-12-0-10.5 FDA UDI
- Primary DI / UDI-DI
- 00827002089952 FDA UDI
- FDA Product Code
- KDJ FDA UDI
- GMDN Term
- Peritoneal dialysis catheter, acute FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5630 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
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
Tenckhoff by Cook Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 II | Pending data |
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Manufacturer
- Manufacturer
- Cook Incorporated
Sources (1)
- FDA UDI 5ab00b46-90ac-45e6-89dc-a38324226066 37 fields · synced Jun 8, 2026