Catalog Number

AES-FCE

Brand Name

NA

Version/Model Number

AES-FCE

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

-

Product Code

GEI

Product Code Name

Electrosurgical, cutting & coagulation & accessories

Public Device Record Key

6005351e-0959-4e83-89fe-1c54e54b3335

Public Version Date

October 14, 2021

Public Version Number

1

DI Record Publish Date

October 06, 2021

Package DI Number

20845854043940

Quantity per Package

1

Contains DI Package

10845854043943

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CARTON