Device |
catheter, ureteral, general & plastic surgery |
Regulation Description |
Urological catheter and accessories. |
Regulation Medical Specialty |
Gastroenterology/Urology |
Review Panel |
Gastroenterology/Urology |
Product Code | GBL |
Premarket Review |
Reproductive, Gynecology and Urology Devices
(DHT3B)
Reproductive, Gynecology and Urology Devices
(DHT3B)
|
Not Classified Reason
|
For Export Only
|
Submission Type |
Contact ODE
|
Regulation Number |
876.5130
|
Device Class |
Not Classified
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Eligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Recognized Consensus Standard
|
Third Party Review
|
Accredited Persons
|