Catalog Number

4630CE

Brand Name

NA

Version/Model Number

4630CE

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

8edf6a80-16bf-4783-addf-54a4f93ece26

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

June 24, 2017

Package DI Number

10812480010311

Quantity per Package

3

Contains DI Package

00812480010314

Package Discontinue Date

January 04, 2018

Package Status

Not in Commercial Distribution

Package Type

Carton