Duns Number:009120817
Device Description: Prostate Procedure Kit containing CVA2400 (4ea), CRYO-55-F (6 ea), CRYO-77 ( 1 ea)
Catalog Number
CRYO-204-V
Brand Name
Prostate Procedure Probe Pack
Version/Model Number
DP35-0965-101
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
17fd8bb3-ee85-425f-b884-a86ee211a10b
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 |