Identity
- Trade Name
- Cook FDA UDI
- Generic Name
- Multi-purpose percutaneous abdominothoracic drainage catheter FDA UDI
- Device Name
- Straight-Drain™ Drainage Catheter Ultrathane® EUDAMEDStraight-Drain Drainage Catheter Ultrathane FDA UDI
- Model / Reference
- ULT12.0-38-40-P-6S-0-USD EUDAMEDG08131 FDA UDI
- Description
- Straight-Drain Drainage Catheter Ultrathane FDA UDI
Identifiers
- Catalog Number
- ULT12.0-38-40-P-6S-0-USD FDA UDI
- Primary DI / UDI-DI
- D-00827002CINC83YT EUDAMED00827002081314 FDA UDI
- Basic UDI-DI
- B-00827002CINC83YT EUDAMED
- FDA Product Code
- LJE FDA UDI
- EMDN Code
- A060201 EXTERNAL DRAINAGE CATHETERS AND KITS (ABSCESSES, GALLSTONES, CYSTS) EUDAMED
- GMDN Term
- Multi-purpose percutaneous abdominothoracic drainage catheter FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDU FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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: Multi-purpose percutaneous abdominothoracic drainage catheter
Cook by Cook Incorporated — Class U — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Multi-purpose percutaneous abdominothoracic drainage catheter.
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class U | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class U | Pending data |
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Manufacturer
- Manufacturer
- Cook Incorporated
Sources (2)
- FDA UDI 02aa7248-ab81-442b-8a96-fd58594f43e7 36 fields · synced Oct 9, 2026
- EUDAMED db8f812a-d043-4a41-ae52-028305b75739 61 fields · synced Oct 9, 2026