Identity
- Trade Name
- Syneture FDA UDI
- Generic Name
- Suture kit, medicated FDA UDI
- Device Name
- Custom Suture Pack,(4) 88862914-51;(4) 88864719-31V;(5) 88864750-41V;(3) CLS-953;(1) CLS-954;(1) CLS-955;(2) CS-17-M;(1) GS-63-M;(2) S-193;(1) S-195;(2) S-608;(4) 88864719-31V;(4) 88864734-11V FDA UDI
- Model / Reference
- US1601 FDA UDI
- Description
- Custom Suture Pack,(4) 88862914-51;(4) 88864719-31V;(5) 88864750-41V;(3) CLS-953;(1) CLS-954;(1) CLS-955;(2) CS-17-M;(1) GS-63-M;(2) S-193;(1) S-195;(2) S-608;(4) 88864719-31V;(4) 88864734-11V FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10884521161641 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 8ee544bf-c705-4189-a2bb-00ad5f0bca5c 36 fields · synced May 30, 2026