Catalog Number

563008516

Brand Name

Equate

Version/Model Number

563008516

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

952a4eb2-8e6f-442f-9eed-c6c01693131e

Public Version Date

July 12, 2018

Public Version Number

3

DI Record Publish Date

April 24, 2017

Package DI Number

20681131162702

Quantity per Package

6

Contains DI Package

00681131162708

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case