Catalog Number

RS-17

Brand Name

RenalCryo™

Version/Model Number

RS-17

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

K153489

Product Code

GEH

Product Code Name

Unit, Cryosurgical, Accessories

Public Device Record Key

4e65f493-9cca-4f0d-9506-5b620ae2a169

Public Version Date

July 03, 2020

Public Version Number

4

DI Record Publish Date

July 31, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-