Catalog Number

-

Brand Name

DemeSORB

Version/Model Number

PGA174019F2P

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

K043539,K043539

Product Code

GAM

Product Code Name

Suture, Absorbable, Synthetic, Polyglycolic Acid

Public Device Record Key

e04a39ea-d704-4a16-ac60-d25266273ae8

Public Version Date

February 05, 2021

Public Version Number

3

DI Record Publish Date

July 26, 2019

Package DI Number

30652927429245

Quantity per Package

12

Contains DI Package

10652927429241

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-