SOPHYSA

GUDID 03760124131512

PRESSIO SERIAL TRANSMITTER

SOPHYSA

Patient monitoring system module, intracranial pressure
Primary Device ID03760124131512
NIH Device Record Key64ffbf0d-6215-4915-a1fe-0ce4f90352ee
Commercial Distribution Discontinuation2023-05-16
Commercial Distribution StatusNot in Commercial Distribution
Brand NameSOPHYSA
Version Model NumberPSO-TX00
Company DUNS262951353
Company NameSOPHYSA
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS103760124131512 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GWMDEVICE, MONITORING, INTRACRANIAL PRESSURE

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2023-05-18
Device Publish Date2016-07-20

On-Brand Devices [SOPHYSA]

03760124132076PRESSIO 2 ICP MONITOR
03760124130676PRESSIO ICP MONITOR
03760124130034ANTI-REFLUX PERITONEAL CATHETER
03760124130027ANTI-REFLUX ATRIAL CATHETER
03760124130010DISTAL ATRIAL/PERITONEAL CATH.
03760124131741POLARIS ADJUSTABLE VALVE, 10-140 WITH ANTICHAMBER AND SIPHONX
03760124131734POLARIS ADJUSTABLE VALVE, 10-140 WITH SIPHONX
03760124131727POLARIS ADJUSTABLE VALVE, 30-200 WITH BURR HOLE RESERVOIR AND SIPHONX
03760124131710POLARIS ADJUSTABLE VALVE, 30-200 WITH ANTECHAMBER AND SIPHONX
03760124131703POLARIS ADJUSTABLE VALVE, 30-200 WITH SIPHONX
03760124131697SIPHONX GRAVITATIONAL ANTI-SIPHON DEVICE
03760124131628POLARIS SPV-400 ADJUSTABLE VALVE/ANTECHAMBER
03760124131611POLARIS SPV-300 ADJUSTABLE VALVE/ANTECHAMBER
03760124131604POLARIS SPV-140 ADJUSTABLE VALVE/ANTECHAMBER
03760124131338POLARIS SPVB KIT PREATTACHED/BO19-10
03760124131321POLARIS SPV ADJUSTABLE VALVE/BURR HOLE RES.
03760124131314POLARIS SPVA KIT PREATTACHED/BO19-10
03760124131307POLARIS SPV ADJUSTABLE VALVE/ANTICHAMBER
03760124131291POLARIS ADJUSTABLE VALVE 400
03760124131284POLARIS ADJUSTABLE VALVE 300
03760124131277POLARIS SPV KIT PREATTACHED/BO19-10
03760124131260POLARIS ADJUSTABLE VALVE 140
03760124131253POLARIS ADJUSTABLE VALVE/5 PRESS.
03760124131246SOPHY SM8B KIT PREATTACHED/BO19-10
03760124131239SOPHY MINI PROG.VALVE/8 PRESS. BURR HOLE
03760124131222SOPHY SM8A KIT PREATTACHED/BO19-10
03760124131215SOPHY MINI PROG.VALVE/8.PRESS. ANTICHAMBER
03760124131161SOPHY SM8 KIT PREATTACHED/PLO7
03760124131154SOPHY SM8 KIT PREATTACHED/PLO6
03760124131147SOPHY SM8 KIT PREATTACHED/PR07
03760124131130SOPHY SM8 KIT PREATTACHED/PRO6
03760124131123SOPHY SM8 KIT PREATTACHED/BO19-10
03760124131116SOPHY SM8 KIT PREATTACHED
03760124131093SOPHY MINI PROG.VALVE/8PRESS.
03760124130171THREE WAY CONNECTOR
13760124130161ASYMMETR.CATH.CONNECT.STRAIGHT
13760124130154SYMMETRI.CATH.CONNECT.STRAIGHT
03760124132007MRI SUPPORT
03760124131772PRESSIO ICP & ICT MONITORING KIT, VENTRICULAR TUNNELING
03760124131765PRESSIO ICP & ICT MONITORING KIT, PARENCHYMAL TUNNELING
03760124131758PRESSIO ICP & ICT MONITORING KIT, PARENCHYMAL W/BOLT
03760124131482PRESSIO ICP MONITORING KIT, VENTRICULAR TUNNELING
03760124130782PRESSIO ICP MONITORING KIT, PARENCHYMAL TUNNELING
03760124130768PRESSIO ICP MONITORING KIT, PARENCHYMAL WITH BOLT
03760124132144POLARIS SETTING INSTRUMENT-3
03760124132137POLARIS READING INSTRUMENT-3
03760124132120POLARIS LOCATING INSTRUMENT-3
03760124132113POLARIS VALVE ADJUSTMENT KIT -3
03760124131512PRESSIO SERIAL TRANSMITTER
03760124131499PRESSIO ICP INTERFACE CONTROL UNIT

Trademark Results [SOPHYSA]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SOPHYSA
SOPHYSA
85058088 4008348 Live/Registered
SOPHYSA
2010-06-09
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.