Sophysa

GUDID 13760124131458

DISPOSABLE TUBUAR SHEATH FOR CATHETER PASSER 65 CM

SOPHYSA

Subcutaneous tunneller, single-use

• Primary Device ID: 13760124131458
• NIH Device Record Key: c32df144-f294-4ffc-870c-55bf54880c19
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sophysa
• Version Model Number: TUG-65
• Company DUNS: 262951353
• Company Name: SOPHYSA
• Device Count: 25
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Unsafe
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	03760124131451 [Primary]
GS1	13760124131458 [Unit of Use]

FDA Product Code

• GYK: Instrument, Shunt System Implantation

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-12
• Device Publish Date: 2023-06-02

On-Brand Devices [Sophysa]

• 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