Catalog Number

269A

Brand Name

VISORB

Version/Model Number

269A

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

GAM

Product Code Name

Suture, Absorbable, Synthetic, Polyglycolic Acid

Public Device Record Key

6e063c22-f600-43df-a14d-e1c9d0710058

Public Version Date

December 10, 2018

Public Version Number

4

DI Record Publish Date

April 22, 2015

Package DI Number

20790986000074

Quantity per Package

12

Contains DI Package

10790986000077

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-