Duns Number:531854560
Device Description: Set of disposable components used in conjunction with a warmer system and peristaltic pump Set of disposable components used in conjunction with a warmer system and peristaltic pump, is intended to warm urethral tissue when performing cryoablative destruction of prostatic tissue with a Galil Medical Cryoablation System
Catalog Number
FPRPR4003
Brand Name
Galil Medical Urethral Warming Set
Version/Model Number
FPRPR4003
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
69d875d8-8621-4caf-b3dc-72bd53b81508
Public Version Date
September 03, 2021
Public Version Number
5
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 |