Catalog Number

-

Brand Name

American Biosurgical

Version/Model Number

CB-4106.033

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"

Yes

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,K971540

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Public Device Record Key

9bef3f11-ed4f-4572-b01e-20ba1beecdc4

Public Version Date

June 11, 2021

Public Version Number

1

DI Record Publish Date

June 03, 2021

Package DI Number

10849593019795

Quantity per Package

10

Contains DI Package

00849593019798

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box