Identity
- Trade Name
- Vilet™ FDA UDI
- Generic Name
- Polyester suture, bioabsorbable, multifilament, non-antimicrobial FDA UDI
- Device Name
- Vilet PGLA 3/0 FS-2 [3/8C RevCt 19mm] 18” Undyed FDA UDI
- Model / Reference
- V393U FDA UDI
- Description
- Vilet PGLA 3/0 FS-2 [3/8C RevCt 19mm] 18” Undyed FDA UDI
Identifiers
- Catalog Number
- V393U FDA UDI
- Primary DI / UDI-DI
- 10841307130635 FDA UDI
- 510(k) Number
- K120556 FDA UDI
- FDA Product Code
- GAM FDA UDI
- GMDN Term
- Polyester suture, bioabsorbable, multifilament, non-antimicrobial FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4493 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
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
Category: Polyester suture, bioabsorbable, multifilament, non-antimicrobial
Vilet™ by Implant Direct Sybron Manufacturing Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Polyester suture, bioabsorbable, multifilament, non-antimicrobial.
- DemeCRYL — DemeTECH Corp · Class II
- DemeCRYL — DemeTECH Corp · Class II
- DemeQUICK — DemeTECH Corp · Class II
- DemeSORB — DemeTECH Corp · Class II
- Coated VICRYL — Ethicon Inc. · Class II
- DemeSORB — DemeTECH Corp · Class II
- Coated VICRYL — Ethicon Inc. · Class II
- DemeSORB — DemeTECH Corp · Class II
Cleared under the same submission
K120556 also covers:
- Velosorb — Covidien LP
- Velosorb Fast — Covidien LP
- Velosorb Fast — Covidien LP
- Velosorb Fast — Covidien LP
- Velosorb Fast — Covidien LP
- Velosorb Fast — Covidien LP
- Velosorb Fast — Covidien LP
- Velosorb Fast — Covidien LP
- Velosorb Fast — Covidien LP
- Velosorb Fast — Covidien LP
- Velosorb Fast — Covidien LP
- Velosorb Fast — Covidien LP
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Implant Direct Sybron Manufacturing Llc
Sources (1)
- FDA UDI b0cc8945-802f-4559-9286-97bb89968a82 37 fields · synced May 30, 2026