Catalog Number

CRF-U1005S

Brand Name

ElectrodeCRF

Version/Model Number

CRF-U1005S

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

K192715,K192715

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Public Device Record Key

f7faf2b8-45ed-48a9-86d3-414356c6e816

Public Version Date

October 26, 2020

Public Version Number

1

DI Record Publish Date

October 16, 2020

Package DI Number

10811746032708

Quantity per Package

5

Contains DI Package

00811746032701

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-