Catalog Number

CRY16

Brand Name

FREEZPOINT™

Version/Model Number

CRY16

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K102006,K102006

Product Code

GEH

Product Code Name

Unit, Cryosurgical, Accessories

Public Device Record Key

2cf47bf0-e735-4dd5-a4fe-8a8b392edce0

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 26, 2016

Package DI Number

10607151010802

Quantity per Package

2

Contains DI Package

00850077006012

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX