Catalog Number

AB 5005 B

Brand Name

AMERICAN BIOSURGICAL

Version/Model Number

AB 5005 B

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

-

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

db209a45-d251-4085-8395-837863b7ae7a

Public Version Date

April 14, 2022

Public Version Number

4

DI Record Publish Date

March 17, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-