Catalog Number

CTT0502

Brand Name

CellFX

Version/Model Number

FG5013-01, FG6016-01

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

K203299,K203299

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Public Device Record Key

6bff134a-bcd7-477c-8188-2f9a7134d0b3

Public Version Date

March 08, 2021

Public Version Number

1

DI Record Publish Date

February 26, 2021

Package DI Number

10850003231669

Quantity per Package

6

Contains DI Package

00850003231662

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-