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
FPRPR4070
Brand Name
IceRod® i-Thaw® Prostate Cryoablation Kit / Presice® System
Version/Model Number
FPRPR4070
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
November 05, 2022
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
0d6e4eb4-fee9-48ad-94eb-bf06ae0b4c66
Public Version Date
September 03, 2021
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 |