Catalog Number

-

Brand Name

DemeDAC

Version/Model Number

PT2X11403

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

K023030,K023030

Product Code

GAT

Product Code Name

Suture, Nonabsorbable, Synthetic, Polyethylene

Public Device Record Key

26eda160-126c-40d3-b6a3-eb3613c7423e

Public Version Date

February 05, 2021

Public Version Number

2

DI Record Publish Date

December 24, 2019

Package DI Number

30652927667845

Quantity per Package

12

Contains DI Package

10652927667841

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-