Catalog Number

-

Brand Name

GIBSON

Version/Model Number

5067-698

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

-

Product Code

NBY

Product Code Name

Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene

Public Device Record Key

60f60bbc-ee64-4f7e-966d-9c09e67aea2b

Public Version Date

June 27, 2018

Public Version Number

3

DI Record Publish Date

September 23, 2016

Package DI Number

10366975002263

Quantity per Package

12

Contains DI Package

00366975002266

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box