Catalog Number

8476

Brand Name

CONVERTORS

Version/Model Number

8476

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

PUI

Product Code Name

Drape, surgical, exempt

Public Device Record Key

56e4e5b3-fa64-4146-b8e3-ae454e8816dc

Public Version Date

December 22, 2021

Public Version Number

3

DI Record Publish Date

August 12, 2020

Package DI Number

50192253025635

Quantity per Package

24

Contains DI Package

00192253025630

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE