Catalog Number

-

Brand Name

Demetech PTFE

Version/Model Number

TE15600,9G0P

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

K181578,K181578

Product Code

NBY

Product Code Name

Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene

Public Device Record Key

d81983e9-c013-4624-82e0-73063e01aecb

Public Version Date

February 05, 2021

Public Version Number

2

DI Record Publish Date

July 10, 2019

Package DI Number

30652927671729

Quantity per Package

12

Contains DI Package

10652927671725

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-