Catalog Number

CP5301

Brand Name

DemeGUT

Version/Model Number

CP133022F4P

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

740e01a1-ebde-41db-b66b-2c2dde96f649

Public Version Date

April 21, 2021

Public Version Number

1

DI Record Publish Date

April 13, 2021

Package DI Number

30652927775151

Quantity per Package

12

Contains DI Package

10652927775157

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-