Catalog Number

017276234794

Brand Name

Care Science

Version/Model Number

017276234794

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

GEH

Product Code Name

Unit, Cryosurgical, Accessories

Public Device Record Key

cdf46596-b072-4bb8-9bf5-c00b8aa46a3a

Public Version Date

February 11, 2019

Public Version Number

1

DI Record Publish Date

January 10, 2019

Package DI Number

10017276234791

Quantity per Package

6

Contains DI Package

00017276234794

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case