Duns Number:009120817
Device Description: Variable ice right angle cryoprobe with 12 ft return hose length for use with Cryocare sys Variable ice right angle cryoprobe with 12 ft return hose length for use with Cryocare systems
Catalog Number
CVA2400RA-12
Brand Name
2.4mm V-Probe™ Cryoprobe Right Angle with 12 ft Return Hose Length
Version/Model Number
DP35-0902-210
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
K201588
Product Code
GEH
Product Code Name
UNIT, CRYOSURGICAL, ACCESSORIES
Public Device Record Key
c317b7e9-f64b-45fa-89ad-d3c1a9ee1c25
Public Version Date
September 09, 2022
Public Version Number
1
DI Record Publish Date
September 01, 2022
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 | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 253 |