Catalog Number

-

Brand Name

DemeCAPRONE

Version/Model Number

MO275015F6P

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

f4092ae5-55d2-403e-a8d1-134f3c26a51a

Public Version Date

October 19, 2021

Public Version Number

1

DI Record Publish Date

October 11, 2021

Package DI Number

30652927728478

Quantity per Package

12

Contains DI Package

10652927728474

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-