Duns Number:017283879
Device Description: ClariFix is a handheld cryotherapy device, which provides focal, controlled freezing to th ClariFix is a handheld cryotherapy device, which provides focal, controlled freezing to the target tissue. The ClariFix device consists of: 1 Cryoprobe (provided sterile), 2 Caps (provided sterile) and 2 Cryogen canisters (provided nonsterile). ClariFix is designed for single patient use.
Catalog Number
-
Brand Name
ClariFix Cryotherapy Device
Version/Model Number
CFX-2000
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)
Yes
Over the Counter (OTC)
-
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
27e5a93c-ebc4-41d4-a0dd-80e1d49c660c
Public Version Date
October 17, 2022
Public Version Number
3
DI Record Publish Date
September 01, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 22 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |