Catalog Number

-

Brand Name

DemeDIOX

Version/Model Number

PX184019F12P

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

K082097,K082097

Product Code

NEW

Product Code Name

Suture, Surgical, Absorbable, Polydioxanone

Public Device Record Key

5f4be60a-8fe4-40ed-9fd3-203ef341d13a

Public Version Date

October 19, 2021

Public Version Number

1

DI Record Publish Date

October 11, 2021

Package DI Number

30652927720038

Quantity per Package

12

Contains DI Package

10652927720034

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-