DEVICE: Titan (05708932487245)
Device Identifier (DI) Information
Titan
ES8820
In Commercial Distribution
ES8820
Coloplast A/S
ES8820
In Commercial Distribution
ES8820
Coloplast A/S
Infrapubic Zero Degree Angle Cylinder Set with Pump
Device Characteristics
MR Conditional | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
36250 | Inflatable penile prosthesis |
An inflatable/deflatable sterile device designed of several interconnected components intended to be surgically implanted in a patient with erectile dysfunction (ED) [commonly known as impotence] in order to achieve selective penile tumescence and rigidity adequate for vaginal intercourse. It is available in a variety of designs and materials and typically consists of: 1) one or two inflatable cylinders implanted into the corpora cavernosa of the penis; 2) a subcutaneous manual pump bulb implanted into the scrotum; 3) a reservoir containing fluid (e.g., saline with/without radiopacifier) implanted in the abdomen; and 4) kink-resistant tubing that connect the component parts.
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FHW | Device, Impotence, Mechanical/Hydraulic |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
P000006 | 001 |
P000006 | 002 |
P000006 | 024 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Keep out of sunlight |
Clinically Relevant Size
[?]Size Type Text |
---|
Length: 20 Centimeter |
Device Record Status
96761019-e855-43d6-b4ce-f0060db2d732
July 06, 2018
3
July 21, 2014
July 06, 2018
3
July 21, 2014
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
8002583476
urology@coloplast.com
urology@coloplast.com