Catalog Number

AB 0510 (S)

Brand Name

AMERICAN BIOSURGICAL

Version/Model Number

AB 0510 (S)

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 13, 2022

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"

Yes

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

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Public Device Record Key

4eefc874-83b7-48da-aeb9-cebf56651565

Public Version Date

April 14, 2022

Public Version Number

3

DI Record Publish Date

April 23, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-