Zimmer - 30" x 4.0" Zimmer ATS Cuff - Blue - Single - HYGIA HEALTH SERVICES, INC.

Duns Number:177939027

Device Description: 30" x 4.0" Zimmer ATS Cuff - Blue - Single Bladder - Single Port - QC

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More Product Details

Catalog Number

-

Brand Name

Zimmer

Version/Model Number

60-7075-105

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 31, 2019

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

0b32c656-fe77-4b31-8d63-4ed201b742af

Public Version Date

March 19, 2021

Public Version Number

3

DI Record Publish Date

February 16, 2018

Additional Identifiers

Package DI Number

50817357022457

Quantity per Package

2

Contains DI Package

30817357022453

Package Discontinue Date

March 19, 2021

Package Status

Not in Commercial Distribution

Package Type

Case

"HYGIA HEALTH SERVICES, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 49
2 A medical device with a moderate to high risk that requires special controls. 178