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Trinity Sterile, Inc.

FDA UDI

Class I (US FDA UDI)

by Trinity Sterile, Inc.

Identity

Trade Name
Trinity Sterile, Inc. FDA UDI
Generic Name
Tourniquet cuff bandage, non-latex FDA UDI
Device Name
TOURN CUFF 18"X4" DISP 2P 1B FDA UDI
Model / Reference
11207 FDA UDI
Description
TOURN CUFF 18"X4" DISP 2P 1B FDA UDI

Identifiers

Primary DI / UDI-DI
10841767106263 FDA UDI
FDA Product Code
GAX FDA UDI
GMDN Term
Tourniquet cuff bandage, non-latex FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.5900 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Ethylene Oxide FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Tourniquet cuff bandage, non-latex

Trinity Sterile, Inc. by Trinity Sterile, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Tourniquet cuff bandage, non-latex.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Trinity Sterile, Inc.

Sources (1)

  • FDA UDI d9e3d079-e09a-48ec-adf9-d06fe71b4820 33 fields · synced May 30, 2026