Catalog Number

29157

Brand Name

CONVERTORS

Version/Model Number

29157

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

fa81cb15-4bb5-45a3-ae36-dd00956de2ec

Public Version Date

December 22, 2021

Public Version Number

3

DI Record Publish Date

October 29, 2018

Package DI Number

50885380164079

Quantity per Package

3

Contains DI Package

10885380164088

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE