Catalog Number

4425CE

Brand Name

NA

Version/Model Number

4425CE

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 04, 2018

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

HKP

Product Code Name

Instrument, Vitreous Aspiration And Cutting, Battery-Powered

Public Device Record Key

5a2f9d54-7464-4d4a-810b-3755ce84ec44

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 23, 2016

Package DI Number

10812480010229

Quantity per Package

3

Contains DI Package

00812480010222

Package Discontinue Date

January 04, 2018

Package Status

Not in Commercial Distribution

Package Type

Carton