Catalog Number

Rx5067B-5

Brand Name

N/A

Version/Model Number

Rx5067B-5

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

e5c20841-1332-4916-9fd4-423446dab63d

Public Version Date

February 16, 2021

Public Version Number

1

DI Record Publish Date

February 08, 2021

Package DI Number

10850003089086

Quantity per Package

5

Contains DI Package

00850003089089

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton