Catalog Number

n/a

Brand Name

n/a

Version/Model Number

102-1144

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 16, 2018

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

K002172

Product Code

GAT

Product Code Name

Suture, Nonabsorbable, Synthetic, Polyethylene

Public Device Record Key

d755a85f-fcc2-4d53-b8ae-313e12064ac2

Public Version Date

February 05, 2021

Public Version Number

6

DI Record Publish Date

October 09, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-