AccessGUDID - DEVICE: T-STRIP (00869193000002)

GUDID

Device Identifier (DI) Information

Brand Name: T-STRIP
Version or Model: TS-001
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: PRECISION MEDICAL DEVICES, LLC

Primary DI Number: 00869193000002
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 25
Labeler D-U-N-S® Number*: 786846571 *Terms of Use

Device Description: The T-Strip is a 2.0 X 7.5 cm porous mesh wound closure strip that allows quick, and easy approximation of the edges of traumatic wounds; while reducing wound tension. The transparent T-Strip allows ideal wound approximation; simply apply to one side of the wound, then gently pull across the wound while aligning the edges. Adhere the remaining adhesive mesh to the other side of the wound, then apply a topical skin adhesive (skin glue) directly on and through the T-strip, sealing the wound.

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:	No
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?
32207	Skin-closure adhesive strip	A small, narrow flexible band (of fabric, plastic, paper, or other material) coated on one side with a pressure-sensitive adhesive, used to approximate the edges of superficial wounds. The device may be hypoallergenic and/or waterproof. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MGO	Closure, Wound, Adhesive

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 [?]
Radiation Sterilization

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: 18b268b8-0888-4a0c-b399-1f3fdf279aa3
Public Version Date: June 23, 2025
Public Version Number: 1
DI Record Publish Date: June 13, 2025