Catalog Number

-

Brand Name

McKesson

Version/Model Number

SX556H

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

K930591,K930591

Product Code

GAT

Product Code Name

Suture, Nonabsorbable, Synthetic, Polyethylene

Public Device Record Key

04e33dd2-8bd7-46df-9db7-6f9d1aa153a2

Public Version Date

February 05, 2021

Public Version Number

5

DI Record Publish Date

December 09, 2016

Package DI Number

20612479213160

Quantity per Package

36

Contains DI Package

10612479213156

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box