Duns Number:305524696
Device Description: Infrapubic OTR Zero Degree Angle Cylinder Set with Pump - Narrow
Catalog Number
ENR811
Brand Name
Titan
Version/Model Number
ENR811
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
P000006,P000006,P000006
Product Code
FHW
Product Code Name
Device, Impotence, Mechanical/Hydraulic
Public Device Record Key
dea76901-1a75-49b0-83bd-9cea235756e0
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
July 21, 2014
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 | 46 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 899 |
| 3 | A medical device with high risk that requires premarket approval | 72 |
| U | Unclassified | 7 |