Duns Number:009120817
Device Description: Right angle 1.7mm cryoprobe, oblong ice, for use with Cryocare systems
Catalog Number
PCS-17
Brand Name
1.7 mm PerCryo™ Cryoprobe
Version/Model Number
DP35-0942-202
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
K153489
Product Code
GEH
Product Code Name
UNIT, CRYOSURGICAL, ACCESSORIES
Public Device Record Key
c61c32ad-5bb6-4fb3-89cc-48ab2b4f9b4a
Public Version Date
February 28, 2022
Public Version Number
1
DI Record Publish Date
February 18, 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 |