Identity
- Trade Name
- Syneture FDA UDI
- Generic Name
- Suture kit, medicated FDA UDI
- Device Name
- Custom Suture Pack,(2) CL-839;(2) CM-845;(2) SM-643;(1) VP-977;(2) VP-72-X;(1) VP-557-X;(3) VP-976-X;(2) VPF-726-X FDA UDI
- Model / Reference
- US1551 FDA UDI
- Description
- Custom Suture Pack,(2) CL-839;(2) CM-845;(2) SM-643;(1) VP-977;(2) VP-72-X;(1) VP-557-X;(3) VP-976-X;(2) VPF-726-X FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10884521160903 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 2cb06873-7779-4c4b-a9a5-24241e33b0e8 36 fields · synced Jun 6, 2026