Catalog Number

202ERT

Brand Name

C-PTFE

Version/Model Number

202ERT

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

K173922,K173922

Product Code

NBY

Product Code Name

Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene

Public Device Record Key

9697c071-b2fa-45e1-b164-c88eff495e48

Public Version Date

February 04, 2019

Public Version Number

1

DI Record Publish Date

January 02, 2019

Package DI Number

20790986007127

Quantity per Package

12

Contains DI Package

10790986007281

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box