Catalog Number

00-2347-051-00

Brand Name

N/A

Version/Model Number

2347-51

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 19, 2017

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

-

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

HWN

Product Code Name

INSTRUMENT, COMPRESSION

Public Device Record Key

99064efa-62a8-49ae-be69-8816d02f33e3

Public Version Date

September 17, 2019

Public Version Number

3

DI Record Publish Date

May 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-