Catalog Number

16-1007A

Brand Name

CARDINAL HEALTH

Version/Model Number

16-1007A

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

KAE

Product Code Name

FORCEPS, ENT

Public Device Record Key

ad71342c-77ae-480b-a145-94c48b1f4cc4

Public Version Date

July 19, 2018

Public Version Number

3

DI Record Publish Date

November 11, 2016

Package DI Number

50885425499050

Quantity per Package

50

Contains DI Package

10885425499052

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE