Identity
- Trade Name
- TRUSILK FDA UDI
- Generic Name
- Silk suture FDA UDI
- Model / Reference
- 5E75DZ26 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08903837047328 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
- 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
No
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
Yes
FDA UDI
Category: Silk suture
Trusilk by Healthium Medtech Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Silk suture.
- Sofsilk — Covidien LP · Class II
- PERMA-HAND — Ethicon Inc. · Class II
- DemeSILK — DemeTECH Corp · Class II
- DemeSILK — DemeTECH Corp · Class II
- DemeSILK — DemeTECH Corp · Class II
- Sofsilk — Covidien LP · Class II
- DemeSILK — DemeTECH Corp · Class II
- DemeSILK — DemeTECH Corp · Class II
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
- Healthium Medtech Limited
Sources (1)
- FDA UDI 4ae9b884-62b2-4f31-bf55-789e7813fa1b 32 fields · synced May 30, 2026