Catalog Number

-

Brand Name

DemeCAPRONE

Version/Model Number

MO283026H6P

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

K130083,K130083

Product Code

GAM

Product Code Name

Suture, Absorbable, Synthetic, Polyglycolic Acid

Public Device Record Key

2a4c3f05-d01b-4ca9-ab42-9115f27c0186

Public Version Date

February 05, 2021

Public Version Number

2

DI Record Publish Date

November 23, 2020

Package DI Number

30652927733175

Quantity per Package

12

Contains DI Package

10652927733171

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-