Catalog Number

S-HO-NOCX-PRXL-S06

Brand Name

CryoProbe™

Version/Model Number

16g cartridges for CryoProbe

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

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

b9ccfae4-9962-4484-8217-85f4d68979e8

Public Version Date

June 10, 2021

Public Version Number

1

DI Record Publish Date

June 02, 2021

Package DI Number

25407008482309

Quantity per Package

12

Contains DI Package

15407008482302

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-