Catalog Number

29580

Brand Name

CONVERTORS

Version/Model Number

29580

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

dde94e05-2e4b-49e7-85da-c2f6ff83417c

Public Version Date

December 22, 2021

Public Version Number

3

DI Record Publish Date

April 09, 2020

Package DI Number

50885380169869

Quantity per Package

8

Contains DI Package

10885380169861

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE