Catalog Number

-

Brand Name

Zimmer Tourniquet

Version/Model Number

RM-60-7080-102

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"

-

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

KCY

Product Code Name

Tourniquet, Pneumatic

Public Device Record Key

82b2abe2-3029-4e84-a0ff-1457f6ec5ede

Public Version Date

August 02, 2019

Public Version Number

3

DI Record Publish Date

March 31, 2017

Package DI Number

10816317022850

Quantity per Package

10

Contains DI Package

00816317022853

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE