Identity
- Trade Name
- Cook Celect FDA UDI
- Generic Name
- Vena cava filter, temporary/permanent FDA UDI
- Device Name
- Cook Celect Platinum, Vena Cava Filter , Femoral Approach FDA UDI
- Model / Reference
- G35590 FDA UDI
- Description
- Cook Celect Platinum, Vena Cava Filter , Femoral Approach FDA UDI
Identifiers
- Catalog Number
- IGTCFS-65-1-FEM-FT-CELECT-PT FDA UDI
- Primary DI / UDI-DI
- 10827002355900 FDA UDI
- 510(k) Number
- K121629 FDA UDI
- FDA Product Code
- DTK FDA UDI
- GMDN Term
- Vena cava filter, temporary/permanent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.3375 FDA UDI
- Commercial Distribution
- Not 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
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
Cook Celect by William Cook Europe ApS — 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
- William Cook Europe ApS
Sources (1)
- FDA UDI f45ea6b2-daca-4295-bd04-a70b52e02ad3 38 fields · synced May 30, 2026