Medical device licence · 13133 · Class 3
TITAN INFLATABLE PENILE PROSTHESIS
Yes: licensed in Canada
Licence status Issued (active); first licensed October 18, 1999. It is in Health Canada’s list of active licences.
- Licence number
- 13133
- Licence holder
- Coloplast Corp.North Mankato, Minnesota, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- October 18, 1999
- Devices covered
- 41
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- TITAN ASSEMBLY KIT
- TITAN INFLAT. PENILE PROS. W/RESIST - NARROW BASE INFRAPUBIC CART./PUMP OTR
- TITAN INFLAT. PENILE PROS. W/RESIST INFRAPUBIC CART./PUMP ONE TCH REL. VALV
- TITAN INFLAT. PENILE PROS. W/RESIST SCROTAL CART./PUMP ONE TOUCH REL. VALVE
- TITAN INFLAT. PENILE PROSTHESIS W/RESIST NAR.BASE INFRAPUBIC CYLINDER/PUMP
- TITAN INFLAT. PENILE PROSTHESIS W/RESIST-NAR.BASE SCROTAL CYLINDER AND PUMP
- TITAN INFLAT. PENILE PROSTHESIS W/RESIST-NARROW BASE SCROTAL CART/PUMP OTR
- TITAN INFLATABLE PENILE PROSTHESIS - CL RESERVOIR
- TITAN INFLATABLE PENILE PROSTHESIS - CYLINDER SET-ZERO ANGLE
- TITAN INFLATABLE PENILE PROSTHESIS - INFRAPUBIC OTR-ZERO DEGREE ANGLE CYLINDER SET WITH PUMP
- TITAN INFLATABLE PENILE PROSTHESIS - INFRAPUBIC-ZERO DEGREE ANGLE CYLINDER SET WITH PUMP
- TITAN INFLATABLE PENILE PROSTHESIS - SCROTAL OTR-ZERO DEGREE ANGLE CYLINDER SET WITH PUMP
- TITAN INFLATABLE PENILE PROSTHESIS - SCROTAL-ZERO DEGREE ANGLE CYLINDER SET WITH PUMP
- TITAN INFLATABLE PENILE PROSTHESIS LOCKOUT VALVE RESERVOIRS WITH RESIST
- TITAN INFLATABLE PENILE PROSTHESIS W/RESIST ASSEMBLY NARROW BASE
- TITAN INFLATABLE PENILE PROSTHESIS WITH RESIST ASSEMBLY KIT
- TITAN INFLATABLE PENILE PROSTHESIS WITH RESIST INFRAPUBIC CYLINDER/PUMP
- TITAN INFLATABLE PENILE PROSTHESIS WITH RESIST SCROTAL CYLINDER AND PUMP
- TITAN IPP NARROW ZERO DEGREE CYLINDERS BOTH INFRAPUBIC AND SCROTAL APPROACH
- TITAN NARROW ASSEMBLY KIT
- TITAN NARROW RTE KIT
- TITAN PRIME CLASSIC PUMP
- TITAN PRIME INFRAPUBIC CYLINDER SET WITH CLASSIC PUMP
- TITAN PRIME INFRAPUBIC CYLINDER SET WITH CLASSIC PUMP, TAILORED
- TITAN PRIME INFRAPUBIC CYLINDER SET WITH PRESS PUMP
- TITAN PRIME INFRAPUBIC CYLINDER SET WITH PRESS PUMP, TAILORED
- TITAN PRIME PRESS PUMP
- TITAN PRIME REAR TIP EXTENDERS
- TITAN PRIME SCROTAL CYLINDER SET WITH CLASSIC PUMP
- TITAN PRIME SCROTAL CYLINDER SET WITH CLASSIC PUMP, TAILORED
- TITAN PRIME SCROTAL CYLINDER SET WITH PRESS PUMP
- TITAN PRIME SCROTAL CYLINDER SET WITH PRESS PUMP, TAILORED
- TITAN PRIME XL CYLINDER SET
- TITAN RTE KIT STANDARD BASE
- TITAN TOUCH NARROW ZERO DEGREE CYLINDERS BOTH INFRAPUBIC AND SCROTAL APPROACH
- TITAN TOUCH PUMP ONLY
- TITAN TOUCH, "INFRAPUBIC" ZERO-DEGREE CYLINDER BASE AND MOLDED CYLINDER TIP
- TITAN TOUCH, "SCROTAL" ZERO-DEGREE CYLINDER BASE AND MOLDED CYLINDER TIP
- TOUCH INFRAPUBIC ZERO DEGREE ANGLE CYLINDER SET WITH PUMP
- TOUCH SCROTAL ZERO DEGREE ANGLE CYLINDER SET WITH PUMP
- TRUE LOCK PLUG
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.