Catalog Number

-

Brand Name

DemeGUT

Version/Model Number

CP16301

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

K072930,K072930

Product Code

GAL

Product Code Name

Suture, Absorbable, Natural

Public Device Record Key

01e82a89-bdb8-4a1b-9bf3-79157ba85317

Public Version Date

February 05, 2021

Public Version Number

2

DI Record Publish Date

July 03, 2019

Package DI Number

30652927268035

Quantity per Package

12

Contains DI Package

10652927268031

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-