MedSource Tourniquet - MEDSOURCE INTERNATIONAL LLC

Duns Number:041674552

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More Product Details

Catalog Number

Not Applicable

Brand Name

MedSource Tourniquet

Version/Model Number

MS-17301-SM

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)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

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

bb87afae-feb9-4ab8-aa33-7f24398be1ba

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

May 10, 2021

Additional Identifiers

Package DI Number

00840155408050

Quantity per Package

100

Contains DI Package

00816703025246

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"MEDSOURCE INTERNATIONAL LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 498
2 A medical device with a moderate to high risk that requires special controls. 90