Catalog Number

5700463

Brand Name

Henry Schein

Version/Model Number

5700463

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

-

Product Code

GAM

Product Code Name

SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Public Device Record Key

dcd9e85b-b5a1-4dcb-b43a-125e4b88b2a9

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

January 10, 2017

Package DI Number

10304040039585

Quantity per Package

12

Contains DI Package

00304040039588

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-