Duns Number:531854560
Device Description: Prostate Kit including Cryoablation Needles, Thermal Sensor, Urethral Warming Set, Prostat Prostate Kit including Cryoablation Needles, Thermal Sensor, Urethral Warming Set, Prostate Template
Catalog Number
FPRPR4518
Brand Name
IceSeed® Prostate Cryoablation Kit / Presice® System
Version/Model Number
FPRPR4518
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)
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
526bef7a-1764-4e34-970e-54fad1773edd
Public Version Date
February 04, 2022
Public Version Number
6
DI Record Publish Date
August 15, 2016
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 47 |