Catalog Number

9545NC

Brand Name

CONVERTORS

Version/Model Number

9545NC

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 01, 2022

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FYA

Product Code Name

GOWN, SURGICAL

Public Device Record Key

0ac7b026-b8a8-42cb-a29b-2348a6837a68

Public Version Date

January 03, 2022

Public Version Number

6

DI Record Publish Date

June 29, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-