Identity
- Trade Name
- Topica Laceration Closure Tray FDA UDI
- Generic Name
- Wound closure set, topical FDA UDI
- Device Name
- The Topical Laceration Closure Tray contains everything needed to topically close uncomplicated laceration and skin avulsions that would otherwise be closed with sutures. The TLC tray contains the T-RING digit tourniquet, the T-Strip wound closure mesh, topical lidocaine gel, 3" x 3" gauze, scissors and benzoin ampule. T-Strip is ideal for Topical Laceration Closure, and is designed to be used with the T-RING digit tourniquet to treat most uncomplicated finger lacerations. The T-Strip can also be used alone to treat superficial lacerations and skin avulsions that occur on other parts of the body. Using the T-Strip and a topical skin adhesive often eliminates the need for laceration trays, painful injections, and sutures; allowing most repairs to be completed in minutes. FDA UDI
- Model / Reference
- TLC 001 FDA UDI
- Description
- The Topical Laceration Closure Tray contains everything needed to topically close uncomplicated laceration and skin avulsions that would otherwise be closed with sutures. The TLC tray contains the T-RING digit tourniquet, the T-Strip wound closure mesh, topical lidocaine gel, 3" x 3" gauze, scissors and benzoin ampule. T-Strip is ideal for Topical Laceration Closure, and is designed to be used with the T-RING digit tourniquet to treat most uncomplicated finger lacerations. The T-Strip can also be used alone to treat superficial lacerations and skin avulsions that occur on other parts of the body. Using the T-Strip and a topical skin adhesive often eliminates the need for laceration trays, painful injections, and sutures; allowing most repairs to be completed in minutes. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00869193000088 FDA UDI
- FDA Product Code
- OVN FDA UDI
- GMDN Term
- Wound closure set, topical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4830 FDA UDI
- Commercial Distribution
- 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
No
FDA UDI
Over-the-Counter
Yes
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
Yes
FDA UDI
Ethylene Oxide FDA UDI
Category: Wound closure set, topical
Topica Laceration Closure Tray by Precision Medical Devices Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Precision Medical Devices Inc
Sources (1)
- FDA UDI 7401e04a-381a-4c63-abaf-a66b50c2743f 34 fields · synced May 31, 2026