Catalog Number

-

Brand Name

DemeLON

Version/Model Number

NL193019F13M

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

K023028,K023028

Product Code

GAR

Product Code Name

Suture, Nonabsorbable, Synthetic, Polyamide

Public Device Record Key

714f10a5-86ab-4baa-b2b5-3528e079bfb5

Public Version Date

February 05, 2021

Public Version Number

2

DI Record Publish Date

July 08, 2019

Package DI Number

30652927263788

Quantity per Package

12

Contains DI Package

10652927263784

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-