Catalog Number

GA-1155N

Brand Name

Onatec

Version/Model Number

GA-1155N

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

b999669b-2f81-4883-8686-c5c644469422

Public Version Date

May 05, 2022

Public Version Number

1

DI Record Publish Date

April 27, 2022

Package DI Number

10848782034113

Quantity per Package

12

Contains DI Package

00848782034116

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box