Identity
- Trade Name
- Cook FDA UDI
- Generic Name
- Surgical capillary wound drain, luminal, synthetic polymer FDA UDI
- Device Name
- Silicone Penrose Drain FDA UDI
- Model / Reference
- G17218 FDA UDI
- Description
- Silicone Penrose Drain FDA UDI
Identifiers
- Catalog Number
- J-SPD-003000 FDA UDI
- Primary DI / UDI-DI
- 00827002172180 FDA UDI
- FDA Product Code
- GCY FDA UDI
- GMDN Term
- Surgical capillary wound drain, luminal, synthetic polymer FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4680 FDA UDI
- Commercial Distribution
- 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
Category: Surgical capillary wound drain, luminal, synthetic polymer
Cook by Cook Incorporated — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Silicone Tubing, Radiopaque — Bentec Medical OpCo, LLC. · Class I
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 d93408b1-cc9f-4e95-a1ff-d8781e1b32df 36 fields · synced Jun 8, 2026