Catalog Number

-

Brand Name

Demetech PTFE

Version/Model Number

TE654019F13M

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

K181578,K181578

Product Code

NBY

Product Code Name

Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene

Public Device Record Key

b9ef19fa-77a3-4e9a-8cde-756e89c2dc64

Public Version Date

February 05, 2021

Public Version Number

2

DI Record Publish Date

January 15, 2020

Package DI Number

30652927695848

Quantity per Package

12

Contains DI Package

10652927695844

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-