Catalog Number

-

Brand Name

American Biosurgical

Version/Model Number

CB-AB 2001 B

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

-

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

K972901,K972901,K972901

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Public Device Record Key

07c69a17-ae9d-4fd4-9fd8-0b390457d06f

Public Version Date

June 10, 2021

Public Version Number

1

DI Record Publish Date

June 02, 2021

Package DI Number

10849593019917

Quantity per Package

10

Contains DI Package

00849593019910

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box