Zimmer Tourniquet - Zimmer Tourniquet 18 in. - RENU MEDICAL, INC

Duns Number:100439103

Device Description: Zimmer Tourniquet 18 in.

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More Product Details

Catalog Number

-

Brand Name

Zimmer Tourniquet

Version/Model Number

RM-60707500300

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

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 Details

Product Code

KCY

Product Code Name

Tourniquet, Pneumatic

Device Record Status

Public Device Record Key

adecfe42-ccd1-471a-8222-d3d3a2cbc486

Public Version Date

August 02, 2019

Public Version Number

3

DI Record Publish Date

June 16, 2017

Additional Identifiers

Package DI Number

10816317023314

Quantity per Package

10

Contains DI Package

00816317023317

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case

"RENU MEDICAL, INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 68
2 A medical device with a moderate to high risk that requires special controls. 95