Identity
- Trade Name
- V-Loc 90 FDA UDI
- Generic Name
- Barbed polyester suture, non-antimicrobial FDA UDI
- Device Name
- Absorbable Wound Closure Device FDA UDI
- Model / Reference
- VLOCM0035 FDA UDI
- Description
- Absorbable Wound Closure Device FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10884521131736 FDA UDI
- 510(k) Number
- K100257 FDA UDI
- FDA Product Code
- GAM FDA UDI
- GMDN Term
- Barbed polyester suture, 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
Dimensions & Sizes
- Size
- Length — 23 Inch FDA UDI
Category: Barbed polyester suture, non-antimicrobial
V-Loc 90 by Covidien LP — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Barbed polyester suture, non-antimicrobial.
- Quill — Surgical Specialties México, S. de R.L. de C.V. · Class II
- V-Loc 90 Delta — Samyang Holdings Corp., Ltd. · Class II
- V-Loc 90 Delta — Samyang Holdings Corp., Ltd. · Class II
- V-Loc 90 Delta — Samyang Holdings Corp., Ltd. · Class II
- V-Loc 90 Delta — Samyang Holdings Corp., Ltd. · Class II
- V-Loc 90 Delta — Samyang Holdings Corp., Ltd. · Class II
- Stratafix Spiral — Surgical Specialties México, S. de R.L. de C.V. · Class II
- Stratafix Spiral — Surgical Specialties México, S. de R.L. de C.V. · Class II
Cleared under the same submission
K100257 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 1a0311ac-9f24-4a99-87f4-e2269ee38ab3 37 fields · synced May 31, 2026