Primary Device ID | 03760124130621 |
NIH Device Record Key | 062653db-5b29-496b-ab4e-24d91b6d068c |
Commercial Distribution Discontinuation | 2023-05-16 |
Commercial Distribution Status | Not in Commercial Distribution |
Brand Name | Sophysa |
Version Model Number | PRO4 |
Company DUNS | 262951353 |
Company Name | SOPHYSA |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | MR Safe |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 03760124130621 [Primary] |
JXG | Shunt, central nervous system and components |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2023-05-18 |
Device Publish Date | 2015-10-16 |
03760124132076 | PRESSIO 2 ICP MONITOR |
03760124130676 | PRESSIO ICP MONITOR |
03760124130034 | ANTI-REFLUX PERITONEAL CATHETER |
03760124130027 | ANTI-REFLUX ATRIAL CATHETER |
03760124130010 | DISTAL ATRIAL/PERITONEAL CATH. |
03760124131741 | POLARIS ADJUSTABLE VALVE, 10-140 WITH ANTICHAMBER AND SIPHONX |
03760124131734 | POLARIS ADJUSTABLE VALVE, 10-140 WITH SIPHONX |
03760124131727 | POLARIS ADJUSTABLE VALVE, 30-200 WITH BURR HOLE RESERVOIR AND SIPHONX |
03760124131710 | POLARIS ADJUSTABLE VALVE, 30-200 WITH ANTECHAMBER AND SIPHONX |
03760124131703 | POLARIS ADJUSTABLE VALVE, 30-200 WITH SIPHONX |
03760124131697 | SIPHONX GRAVITATIONAL ANTI-SIPHON DEVICE |
03760124131628 | POLARIS SPV-400 ADJUSTABLE VALVE/ANTECHAMBER |
03760124131611 | POLARIS SPV-300 ADJUSTABLE VALVE/ANTECHAMBER |
03760124131604 | POLARIS SPV-140 ADJUSTABLE VALVE/ANTECHAMBER |
03760124131338 | POLARIS SPVB KIT PREATTACHED/BO19-10 |
03760124131321 | POLARIS SPV ADJUSTABLE VALVE/BURR HOLE RES. |
03760124131314 | POLARIS SPVA KIT PREATTACHED/BO19-10 |
03760124131307 | POLARIS SPV ADJUSTABLE VALVE/ANTICHAMBER |
03760124131291 | POLARIS ADJUSTABLE VALVE 400 |
03760124131284 | POLARIS ADJUSTABLE VALVE 300 |
03760124131277 | POLARIS SPV KIT PREATTACHED/BO19-10 |
03760124131260 | POLARIS ADJUSTABLE VALVE 140 |
03760124131253 | POLARIS ADJUSTABLE VALVE/5 PRESS. |
03760124131246 | SOPHY SM8B KIT PREATTACHED/BO19-10 |
03760124131239 | SOPHY MINI PROG.VALVE/8 PRESS. BURR HOLE |
03760124131222 | SOPHY SM8A KIT PREATTACHED/BO19-10 |
03760124131215 | SOPHY MINI PROG.VALVE/8.PRESS. ANTICHAMBER |
03760124131161 | SOPHY SM8 KIT PREATTACHED/PLO7 |
03760124131154 | SOPHY SM8 KIT PREATTACHED/PLO6 |
03760124131147 | SOPHY SM8 KIT PREATTACHED/PR07 |
03760124131130 | SOPHY SM8 KIT PREATTACHED/PRO6 |
03760124131123 | SOPHY SM8 KIT PREATTACHED/BO19-10 |
03760124131116 | SOPHY SM8 KIT PREATTACHED |
03760124131093 | SOPHY MINI PROG.VALVE/8PRESS. |
03760124130171 | THREE WAY CONNECTOR |
13760124130161 | ASYMMETR.CATH.CONNECT.STRAIGHT |
13760124130154 | SYMMETRI.CATH.CONNECT.STRAIGHT |
03760124132007 | MRI SUPPORT |
03760124131772 | PRESSIO ICP & ICT MONITORING KIT, VENTRICULAR TUNNELING |
03760124131765 | PRESSIO ICP & ICT MONITORING KIT, PARENCHYMAL TUNNELING |
03760124131758 | PRESSIO ICP & ICT MONITORING KIT, PARENCHYMAL W/BOLT |
03760124131482 | PRESSIO ICP MONITORING KIT, VENTRICULAR TUNNELING |
03760124130782 | PRESSIO ICP MONITORING KIT, PARENCHYMAL TUNNELING |
03760124130768 | PRESSIO ICP MONITORING KIT, PARENCHYMAL WITH BOLT |
03760124132144 | POLARIS SETTING INSTRUMENT-3 |
03760124132137 | POLARIS READING INSTRUMENT-3 |
03760124132120 | POLARIS LOCATING INSTRUMENT-3 |
03760124132113 | POLARIS VALVE ADJUSTMENT KIT -3 |
03760124131512 | PRESSIO SERIAL TRANSMITTER |
03760124131499 | PRESSIO ICP INTERFACE CONTROL UNIT |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SOPHYSA 85058088 4008348 Live/Registered |
SOPHYSA 2010-06-09 |