Identity
- Trade Name
- Syneture FDA UDI
- Generic Name
- Suture kit, medicated FDA UDI
- Device Name
- Custom Suture Pack,(1) 88868619-03;(2) CL-810;(1) CL-880;(2) CL-952;(3) CL-954;(1) CL-975;(1) CP-434;(4) GS-833;(2) S-317;(1) S-403;(1) S-405;(2) SC-5780G;(4) VP-205-X;(6) VP-558-X;(1) VP-735-X;(4) VP-772-X FDA UDI
- Model / Reference
- US1349A FDA UDI
- Description
- Custom Suture Pack,(1) 88868619-03;(2) CL-810;(1) CL-880;(2) CL-952;(3) CL-954;(1) CL-975;(1) CP-434;(4) GS-833;(2) S-317;(1) S-403;(1) S-405;(2) SC-5780G;(4) VP-205-X;(6) VP-558-X;(1) VP-735-X;(4) VP-772-X FDA UDI
Identifiers
- Catalog Number
- US1349A FDA UDI
- Primary DI / UDI-DI
- 10884521159884 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 064e5d59-4795-46c9-9c81-e607ca0ec3e7 37 fields · synced Jun 8, 2026