Catalog Number

-

Brand Name

DemeLENE

Version/Model Number

PM297010C0P

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

K043330,K043330

Product Code

GAW

Product Code Name

Suture, Nonabsorbable, Synthetic, Polypropylene

Public Device Record Key

a1138069-88a5-4da2-b5ce-9c47cb20defa

Public Version Date

February 05, 2021

Public Version Number

2

DI Record Publish Date

October 12, 2020

Package DI Number

30652927722551

Quantity per Package

12

Contains DI Package

10652927722557

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-