Catalog Number

S-HO-NOCX-PR-12-S06

Brand Name

CryoProbe

Version/Model Number

16g N2O cartridges

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K024009,K024009,K024009

Product Code

GEH

Product Code Name

Unit, Cryosurgical, Accessories

Public Device Record Key

0602b87c-5291-45c1-87cc-df92a4c5de46

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

B386SHONOCXPR12S062

Quantity per Package

12

Contains DI Package

B386SHONOCXPR12S061

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-