Catalog Number

-

Brand Name

Premium UNIFY PGA Sutures

Version/Model Number

PMGU-318R19

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)

-

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

3f826ca9-3116-4fd2-842f-962784c6a227

Public Version Date

February 05, 2021

Public Version Number

5

DI Record Publish Date

November 04, 2016

Package DI Number

40814639023037

Quantity per Package

100

Contains DI Package

30814639023030

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case