Topica Laceration Closure Tray

Basic Information

• Brand Name: Topica Laceration Closure Tray
• Primary DI: 00869193000088
• Version / Model: TLC 001
• Company Name: PRECISION MEDICAL DEVICES, LLC
• Labeler DUNS: 786846571
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2025-06-14
• Public Version: 1
• Public Version Date: 2025-06-23
• Public Version Status: New
• Public Device Record Key: 7401e04a-381a-4c63-abaf-a66b50c2743f

Device 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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OVN	Suture Kit	General, Plastic Surgery	878.4830	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46880	Wound closure set, topical	A collection of sterile devices used to topically close easily-approximated skin edges of wounds. It typically includes a pressure-sensitive adhesive tape or mesh and a liquid adhesive, each contained within a dispensing applicator. The tape/mesh is first applied to temporarily approximate the skin edges followed by application of the liquid adhesive, over the tape/mesh, which polymerizes to affect wound closure. This set may be used to treat surgical incisions, simple lacerations, and may also be used in conjunction with deep dermal stitches. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00869193000071	GS1
Primary	00869193000088	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]