Identity
- Trade Name
- Cook FDA UDI
- Generic Name
- Biliary drain FDA UDI
- Device Name
- Biliary Drainage Catheter Ultrathane FDA UDI
- Model / Reference
- G08779 FDA UDI
- Description
- Biliary Drainage Catheter Ultrathane FDA UDI
Identifiers
- Catalog Number
- ULT6.0-38-40-P-32S-BCL FDA UDI
- Primary DI / UDI-DI
- 00827002087798 FDA UDI
- FDA Product Code
- LJE FDA UDI
- GMDN Term
- Biliary drain FDA UDI
Classification
- Device Class
- U 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
Yes
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
No
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: Biliary drain
Cook by Cook Incorporated — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Biliary drain.
- PLASTİ-MED — Plasti-med Plastik Medikal Ürünler San. ve Tic. Ltd. Şti. · Class IIa
- DRENTECH PUMP 400 ML SET SERBATOIO E DRENAGGIO TONDO C/AGO CH 10 — Redax S.p.A. · Class IIa
- Flexima™ — Boston Scientific · Class II
- LMI BILUMEN BILIARY CATHETER DISTAL — LUCAS MEDICAL INC · Class II
- Redondrain PU Ch.12 Länge 800 mm / Perforation 150 mm, graduiert, röntgenfähig steril, gewickelt, DEHP frei — Primed Halberstadt Medizintechnik GmbH · Class IIa
- Biliary Plastic Stent — Micro-Tech (Nanjing) Co., Ltd. · Class II
- Biliary Plastic Stent Set — Micro-Tech (Nanjing) Co., Ltd. · Class II
- Biliary Plastic Stent Set — Micro-Tech (Nanjing) Co., Ltd. · 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 U | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Cook Incorporated
Sources (1)
- FDA UDI c45e3d72-36fa-4d78-b21d-648234844559 36 fields · synced Jun 8, 2026