Identity
- Trade Name
- Sofsilk FDA UDI
- Generic Name
- Silk suture FDA UDI
- Device Name
- Wax Coated Braided Silk,SC-1,1x Black Strand FDA UDI
- Model / Reference
- SS-522 FDA UDI
- Description
- Wax Coated Braided Silk,SC-1,1x Black Strand FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10884521176027 FDA UDI
- 510(k) Number
- K981128 FDA UDI
- FDA Product Code
- GAP FDA UDI
- GMDN Term
- Silk suture FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.5030 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
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 30 Inch FDA UDI
Sofsilk by Covidien LP — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K981128 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 II | Pending data |
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Manufacturer
- Manufacturer
- Covidien LP
Sources (1)
- FDA UDI 0f4900fc-7514-4f39-a483-a910628d7cd5 38 fields · synced Jun 8, 2026