Catalog Number

-

Brand Name

Frigitronics

Version/Model Number

5214

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"

Yes

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

K760742

Product Code

GEH

Product Code Name

Unit, Cryosurgical, Accessories

Public Device Record Key

d6f6403e-8230-4d1e-9a4a-4600102e0a93

Public Version Date

April 07, 2021

Public Version Number

4

DI Record Publish Date

October 17, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-