| Proprietary Name: |
Accessory for pacemaker, ICD and CRT-D Permanent magnet; Accessory for pacemaker, ICD and CRT-D Screw driver; CPR3 wand; Isoline 2CR; Isoline 2CT; Kit accessories BJF24D; Kit accessories BJF25D; Kit accessories BRF24D; Kit accessories BRF25D; Kit accessories BRF26D; Kit accessories BTF25D; Kit accessories BTF26D; Kit accessories Isoline 2CR5; Kit accessories Isoline 2CR6; Kit accessories Isoline 2CT5; Kit accessories Isoline 2CT6; kit accessory BR46D; Kit stilet Situs UW28D; Orchestra Plus; Paradym DR 8550; Paradym VR 8250 |
| Classification Name: |
DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER |
| Product Code: |
MRM |
| Device Class: |
3 |
| Registered Establishment Name: |
Sorin Group Italia Srl - CRM facility
|
| Registered Establishment Number: |
1000165971
|
| Owner/Operator: |
SORIN BIOMEDICA CRM, S.R.L. |
| Owner/Operator Number: |
9059364
|
| Establishment Operations: |
Manufacturer; Repackager/Relabeler
|
