Catalog Number

CB-AB 6003-0 (S)

Brand Name

American Biosurgical

Version/Model Number

AB 6003-0 (S)

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 06, 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"

-

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

K953889

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Public Device Record Key

fbca31b9-3037-40c9-955a-101a431e849f

Public Version Date

October 10, 2022

Public Version Number

2

DI Record Publish Date

September 21, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-