Catalog Number

-

Brand Name

American Biosurgical

Version/Model Number

CB-AB 5003-G-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

K971540,K971540

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Public Device Record Key

f824fc01-b80d-47e4-99ea-01c32fc30020

Public Version Date

September 30, 2021

Public Version Number

2

DI Record Publish Date

June 03, 2021

Package DI Number

00849593019606

Quantity per Package

100

Contains DI Package

00849593019590

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case