Catalog Number

-

Brand Name

DemeLENE

Version/Model Number

PM2x69800,9G0P

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

e4e528f1-7925-4a2f-b2d4-7d9a6df2be46

Public Version Date

October 14, 2021

Public Version Number

1

DI Record Publish Date

October 06, 2021

Package DI Number

30652927724845

Quantity per Package

12

Contains DI Package

10652927724841

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-