T-STRIP

Basic Information

• Brand Name: T-STRIP
• Primary DI: 00869193000002
• Version / Model: TS-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: 2025-06-13
• Public Version: 1
• Public Version Date: 2025-06-23
• Public Version Status: New
• Public Device Record Key: 18b268b8-0888-4a0c-b399-1f3fdf279aa3

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

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• 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: Yes
• 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: Radiation Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MGO	Closure, Wound, Adhesive	General, Plastic Surgery	878.4018	1

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00869193000002	GS1
Unit of Use	00869193000033	GS1

Customer Contacts

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