Identity
- Trade Name
- Syneture FDA UDI
- Generic Name
- Suture kit, medicated FDA UDI
- Device Name
- Custom Suture Pack,(1) 88863008-51;(1) 88863185-41;(2) 88863256-51;(3) 88863271-41;(2) CL-813;(3) CL-953;(3) CS-85-M;(1) GS-833;(2) S-608;(3) SM-5637;(1) VP-557-X;(4) VP-558-X;(1) VP-710-X;(1) VP-713-X FDA UDI
- Model / Reference
- US1254 FDA UDI
- Description
- Custom Suture Pack,(1) 88863008-51;(1) 88863185-41;(2) 88863256-51;(3) 88863271-41;(2) CL-813;(3) CL-953;(3) CS-85-M;(1) GS-833;(2) S-608;(3) SM-5637;(1) VP-557-X;(4) VP-558-X;(1) VP-710-X;(1) VP-713-X FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10884521159655 FDA UDI
- FDA Product Code
- OVN FDA UDI
- GMDN Term
- Suture kit, medicated FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4830 FDA UDI
- Commercial Distribution
- Not 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
Yes
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
No
FDA UDI
Syneture by Covidien LP — 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
- Covidien LP
Sources (1)
- FDA UDI d98061ad-662d-43a9-9da0-5c2b39d52ac5 36 fields · synced May 31, 2026