Identity
- Trade Name
- TLS FDA UDI
- Generic Name
- Closed-wound drainage kit FDA UDI
- Device Name
- 10 French Drain System, Sterile FDA UDI
- Model / Reference
- 6650 FDA UDI
- Description
- 10 French Drain System, Sterile FDA UDI
Identifiers
- Catalog Number
- 6650 FDA UDI
- Primary DI / UDI-DI
- 37613252088470 FDA UDI
- 510(k) Number
- K833586 FDA UDI
- FDA Product Code
- GCY FDA UDI
- GMDN Term
- Closed-wound drainage kit FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4680 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
Tls by Stryker Leibinger — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K833586 also covers:
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
- Stryker Leibinger
Sources (1)
- FDA UDI 1b4bb56a-ea61-4ba8-974c-0f4575a9f5d6 36 fields · synced May 30, 2026