Zimmer Tourniquet - Zimmer Tourniquet 12 in. DPSB 60-7070-102-00 - RENU MEDICAL, INC

Duns Number:100439103

Device Description: Zimmer Tourniquet 12 in. DPSB 60-7070-102-00

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

Zimmer Tourniquet

Version/Model Number

RM-60-7070-102-00

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"

-

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

KCY

Product Code Name

Tourniquet, Pneumatic

Device Record Status

Public Device Record Key

e6e21785-e354-47b5-bfdb-19642119f997

Public Version Date

May 10, 2021

Public Version Number

4

DI Record Publish Date

June 27, 2019

Additional Identifiers

Package DI Number

10816317023574

Quantity per Package

10

Contains DI Package

00816317023577

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"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