Catalog Number

P1658

Brand Name

Medline Industries, Inc.

Version/Model Number

P1658

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

GAX

Product Code Name

TOURNIQUET, NONPNEUMATIC

Public Device Record Key

44b47f30-d338-4efa-93f2-2f4bbebe24a2

Public Version Date

August 12, 2022

Public Version Number

1

DI Record Publish Date

August 04, 2022

Package DI Number

40889942007296

Quantity per Package

12

Contains DI Package

10889942007295

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE