Catalog Number

CB-AB 6003-5 (S)

Brand Name

American Biosurgical

Version/Model Number

AB 6003

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,K953889

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Public Device Record Key

f8e0d5be-17f1-4d87-8f51-969819b5305d

Public Version Date

July 01, 2021

Public Version Number

1

DI Record Publish Date

June 23, 2021

Package DI Number

10849593024843

Quantity per Package

10

Contains DI Package

00849593024846

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box