Catalog Number

5700468

Brand Name

Henry Schein

Version/Model Number

5700468

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

K131224,K131224

Product Code

GAW

Product Code Name

SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Public Device Record Key

ef1ca2c4-ef56-497b-87fc-1ca4709922a9

Public Version Date

August 29, 2022

Public Version Number

7

DI Record Publish Date

January 10, 2017

Package DI Number

10304040039622

Quantity per Package

12

Contains DI Package

00304040039625

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-