Duns Number:928955509
Device Description: Urethral Warming catheter for use in tissue warmning during cryosurgical procedures with t Urethral Warming catheter for use in tissue warmning during cryosurgical procedures with the Cryocare systems
Catalog Number
CRYO-77
Brand Name
Urethral Warming Catheter Kit
Version/Model Number
DP40-0141-106
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
K211149
Product Code
GEH
Product Code Name
UNIT, CRYOSURGICAL, ACCESSORIES
Public Device Record Key
e13d44ed-ba25-4597-b7fb-c7e97a5d4b37
Public Version Date
February 11, 2022
Public Version Number
1
DI Record Publish Date
February 03, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 36 |