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Prestigepro

FDA UDI

Class I (US FDA UDI)

by Prestige Ameritech

Identity

Trade Name
PRESTIGEPRO FDA UDI
Generic Name
Venous tourniquet, single-use FDA UDI
Device Name
Stretch Tourniquets, 1in x 18in, Blue, Single Use, Non-Sterile, Rolled and Banded, 100 per bag FDA UDI
Model / Reference
6431 FDA UDI
Description
Stretch Tourniquets, 1in x 18in, Blue, Single Use, Non-Sterile, Rolled and Banded, 100 per bag FDA UDI

Identifiers

Catalog Number
6431 FDA UDI
Primary DI / UDI-DI
00840490800038 FDA UDI
FDA Product Code
GAX FDA UDI
GMDN Term
Venous tourniquet, single-use 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

No

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

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Venous tourniquet, single-use

Prestigepro by Prestige Ameritech — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Venous tourniquet, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Prestige Ameritech

Sources (1)

  • FDA UDI de6b77ff-0ee8-436a-9c5b-64e8851740cf 35 fields · synced Jun 9, 2026