Catalog Number

-

Brand Name

DemeDIOX

Version/Model Number

PX185017F0P

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

84966350-e871-4525-b27c-f5d5af00ed32

Public Version Date

February 05, 2021

Public Version Number

2

DI Record Publish Date

October 08, 2020

Package DI Number

30652927722582

Quantity per Package

12

Contains DI Package

10652927722588

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-