Catalog Number

-

Brand Name

McKesson

Version/Model Number

SJ443H

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"

-

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

K963253,K963253

Product Code

GAM

Product Code Name

Suture, Absorbable, Synthetic, Polyglycolic Acid

Public Device Record Key

8c9d3777-038b-4623-af70-d8fa8ecb1d9c

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

December 09, 2016

Package DI Number

20612479213481

Quantity per Package

36

Contains DI Package

10612479213477

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box