Catalog Number

CRA-TBK-1

Brand Name

AVANOS

Version/Model Number

CRA-TBK-1

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

-

Product Code

GXI

Product Code Name

Probe, radiofrequency lesion

Public Device Record Key

4626d646-9bfa-4a07-96aa-2922f7c7e407

Public Version Date

December 27, 2021

Public Version Number

2

DI Record Publish Date

March 11, 2021

Package DI Number

10193493000194

Quantity per Package

5

Contains DI Package

00193493000197

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS