Catalog Number

C9011

Brand Name

CONVERTORS

Version/Model Number

C9011

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

FYA

Product Code Name

GOWN, SURGICAL

Public Device Record Key

8e5fd92f-f7d5-4c6b-952b-fcdc5e8f9381

Public Version Date

April 07, 2021

Public Version Number

3

DI Record Publish Date

April 02, 2019

Package DI Number

50192253010594

Quantity per Package

20

Contains DI Package

10192253010596

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE