Catalog Number

5067-6

Brand Name

N/A

Version/Model Number

N/A

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

Yes

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

HOC

Product Code Name

Clip, Iris Retractor

Public Device Record Key

4479f6aa-aa56-497d-a7cc-f94406d4297a

Public Version Date

June 11, 2018

Public Version Number

2

DI Record Publish Date

April 04, 2018

Package DI Number

30818255010238

Quantity per Package

30

Contains DI Package

10818255010234

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton