Propper Velket Tourniquet - Velket - Single, Adult Size, Universal - PROPPER MANUFACTURING COMPANY, INC.

Duns Number:001483130

Device Description: Velket - Single, Adult Size, Universal

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More Product Details

Catalog Number

22101100

Brand Name

Propper Velket Tourniquet

Version/Model Number

22101100

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

GAX

Product Code Name

Tourniquet, Nonpneumatic

Device Record Status

Public Device Record Key

1b4c3041-aea8-424e-8003-393d6dddf47f

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

October 16, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PROPPER MANUFACTURING COMPANY, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 58
2 A medical device with a moderate to high risk that requires special controls. 49