Catalog Number

-

Brand Name

American Biosurgical

Version/Model Number

CB-AB 1000-B-NS

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K953889,K953889

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Public Device Record Key

704be7d1-614b-4fd9-9d15-29612c470c34

Public Version Date

July 13, 2021

Public Version Number

2

DI Record Publish Date

June 02, 2021

Package DI Number

00849593019545

Quantity per Package

200

Contains DI Package

00849593019538

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case