Catalog Number

30-134-6

Brand Name

N/A

Version/Model Number

30-134-6

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

299b87d7-b7ce-46ee-9e4c-eb47db8f1cca

Public Version Date

March 18, 2021

Public Version Number

1

DI Record Publish Date

March 10, 2021

Package DI Number

10850003089208

Quantity per Package

6

Contains DI Package

00850003089201

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton