Catalog Number

003680041112

Brand Name

TopCare

Version/Model Number

003680041112

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

cf338b47-e130-419f-bceb-42c0de7426bc

Public Version Date

July 12, 2018

Public Version Number

3

DI Record Publish Date

August 31, 2016

Package DI Number

10036800411125

Quantity per Package

6

Contains DI Package

00036800411128

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case