Catalog Number

9447

Brand Name

CONVERTORS

Version/Model Number

9447

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

ERY

Product Code Name

Drape, surgical, ent

Public Device Record Key

db7a32c7-8791-4d57-a8e8-726c5b77d1f1

Public Version Date

July 20, 2018

Public Version Number

3

DI Record Publish Date

November 07, 2017

Package DI Number

50885380138995

Quantity per Package

8

Contains DI Package

10885380138997

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE