Catalog Number

29476

Brand Name

CONVERTORS

Version/Model Number

29476

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

77197c43-ad5c-4209-84a0-d3f2e47e3209

Public Version Date

December 22, 2021

Public Version Number

6

DI Record Publish Date

January 17, 2018

Package DI Number

50885380152571

Quantity per Package

10

Contains DI Package

10885380152573

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

EACH