FDA.reportPublic FDA data

T-STRIP

Primary DI
00869193000002
Brand
T-STRIP
Company
PRECISION MEDICAL DEVICES, LLC
Model
TS-001
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.
Published
2025-06-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MGOClosure, Wound, Adhesive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MGOClosure, Wound, AdhesiveGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00869193000002PrimaryGS10
00869193000033Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00869193000002008691930000028691930000020869193000002
00869193000033008691930000338691930000330869193000033

GMDN Terms#

Term, Definition table
TermDefinition
Skin-closure adhesive stripA 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.

Sterilization Methods#

Method table
Method
Radiation Sterilization

Contacts#

Phone, Email table
PhoneEmail
3027792335wgreen@thetring.com

Regulatory Flags#

DUNS number
786846571
Device count
25
DM exempt
true
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00869193000088Topica Laceration Closure TrayTLC 0012025-06-14
00869193000071Topica Laceration Closure TrayTLC 0012025-06-14
00869193000057T-RING FLEX Digit TourniquetTR0022025-06-11
00869193000040T-RING FLEX Digit TourniquetTR0022025-06-11
10869193000016T-RING Digit TourniquetTR0012025-06-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06931132228007SEQUAhold WOUND CLOSURE DEVICEFoshan United Medical Technologies Ltd.MGO2026-05-09
00324357410016Zeni MedicalFocus Health Group, Inc.MGO2026-04-13
00324357410023Zeni MedicalFocus Health Group, Inc.MGO2026-04-13
00324357410030Zeni MedicalFocus Health Group, Inc.MGO2026-04-13
00324357410047Zeni MedicalFocus Health Group, Inc.MGO2026-04-13
00324357410054Zeni MedicalFocus Health Group, Inc.MGO2026-04-13
00324357410061Zeni MedicalFocus Health Group, Inc.MGO2026-04-13
00850065122076Vitale CELLERA LLCMGO2025-07-17
00850005565956VitaleCELLERA LLCMGO2023-02-15
00850005565970VitaleCELLERA LLCMGO2023-02-15
00850031608054VitaleCELLERA LLCMGO2023-02-15
00850031608573Vitale CELLERA LLCMGO2023-02-01
00850031608597Vitale CELLERA LLCMGO2023-02-01
00850031608610Vitale CELLERA LLCMGO2023-02-01
00850005565932VitaleCELLERA LLCMGO2021-11-02
00850005565901VitaleCELLERA LLCMGO2021-10-31
10080196669790MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.MGO2021-05-19
40080196669791MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.MGO2021-05-19