Catalog Number

-

Brand Name

DemeLENE

Version/Model Number

PM3X990175F4P

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

8c0c2220-0368-4a80-b4ba-db006c7a8d7d

Public Version Date

October 14, 2021

Public Version Number

1

DI Record Publish Date

October 06, 2021

Package DI Number

30652927727952

Quantity per Package

12

Contains DI Package

10652927727958

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-