AccessGUDID - DEVICE: Topica Laceration Closure Tray (00869193000088)

GUDID

Device Identifier (DI) Information

Brand Name: Topica Laceration Closure Tray
Version or Model: TLC 001
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: PRECISION MEDICAL DEVICES, LLC

Primary DI Number: 00869193000088
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 25
Labeler D-U-N-S® Number*: 786846571 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OVN	Suture Kit

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7401e04a-381a-4c63-abaf-a66b50c2743f
Public Version Date: June 23, 2025
Public Version Number: 1
DI Record Publish Date: June 14, 2025