Phoenix Neuro

GUDID 03760124134315

Kubala External Drainage Catheter, 35 cm

SOPHYSA

Intracerebral infusion/drainage catheter, short-term

• Primary Device ID: 03760124134315
• NIH Device Record Key: 2519d3b0-5b02-4c6b-89a6-36b4b7600ed0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Phoenix Neuro
• Version Model Number: FVPC4
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	03760124134315 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K853365

FDA Product Code

• JXG: Shunt, central nervous system and components

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-07-22
• Device Publish Date: 2015-10-16

On-Brand Devices [Phoenix Neuro]

• 03760124136678: Closed-Pliant Peritoneal Catheter, 90 cm
• 03760124135046: Open-End Atrial Catheter, Vision, 45 cm
• 03760124134599: Open-end extension tube, 15 cm
• 03760124134582: Open-Pliant Peritoneal Catheter, 90 cm
• 03760124136944: Single Valve Kit, Medium Pressure
• 03760124136937: Single Valve Kit, Low Pressure
• 03760124136920: Single Valve Kit, Very Low Pressure
• 03760124136234: Neonatal Straight Stainless Steel Connector
• 03760124135374: CRx Valve Kit, Very Low Pressure
• 03760124135343: CRx Valve Kit, Low Pressure
• 03760124135312: CRx Valve Kit, Medium Pressure
• 03760124135282: CRx Valve Kit, Normal Pressure
• 03760124135251: CRx Valve Kit, High Pressure
• 03760124135244: CRx Universal Shunt, 11 cm ventricular catheter, High Pressure
• 03760124135237: CRx Universal Shunt, 11 cm ventricular catheter, Medium Pressure
• 03760124135220: CRx Universal Shunt, 11 cm ventricular catheter, Low Pressure
• 03760124134223: "Y" Stainless Steel Connector
• 03760124134216: "T" Stainless Steel Connector
• 03760124134209: Step Stainless Steel Connector
• 13760124134183: Straight Stainless Steel Connector
• 03760124134179: CRx Universal Shunt, 8 cm ventricular catheter, High Pressure
• 03760124134162: CRx Universal Shunt, 8 cm ventricular catheter, Medium Pressure
• 03760124134155: CRx Universal Shunt, 8 cm ventricular catheter, Low Pressure
• 03760124134148: CRx Valve, High Pressure
• 03760124134131: CRx Valve, Medium-High Pressure
• 03760124134124: CRx Valve, Medium Pressure
• 03760124134117: CRx Valve, Low Pressure
• 03760124134094: CRx Valve, Very Low Pressure
• 13760124134077: Right Angle Stainless Steel Connector
• 03760124133936: SINGLE VALVE, MEDIUM PRESSURE
• 03760124133929: SINGLE VALVE, LOW PRESSURE
• 03760124133912: SINGLE VALVE, VERY LOW PRESSURE
• 03760124135985: Fifth Ventricle Spiral-Port Ventricular Catheter, length 35 cm
• 03760124134315: Kubala External Drainage Catheter, 35 cm
• 03760124134308: Fifth Ventricle Spiral-Port Ventricular Catheter, length 23,5 cm
• 03760124136616: Perf (Ommaya Style) Reservoir, bottom-inlet, 19 mm
• 03760124135015: Standard cap Rickham type reservoir, polysulfone base
• 03760124134537: Perf (Ommaya Style) Reservoir, side-arm inlet, 19 mm
• 03760124136708: Straight Spiral-Port Ventricular Catheter, 23,5 cm
• 03760124136548: Right-angle, NN Anti-blok catheter, intraventricular length = 4 cm
• 03760124136531: Right-angle, NN Anti-blok catheter, intraventricular length = 3 cm
• 03760124136494: Right-angle, NN Anti-blok catheter, intraventricular length = 9 cm
• 03760124136487: Right-angle, NN Anti-blok catheter, intraventricular length = 8 cm
• 03760124136470: Right-angle, NN Anti-blok catheter, intraventricular length = 7 cm
• 03760124136463: Right-angle, NN Anti-blok catheter, intraventricular length = 6 cm
• 03760124136456: Right-angle, NN Anti-blok catheter, intraventricular length = 5 cm
• 03760124136326: Pediatric Right Angle ventricular catheter, Vision, 9 cm
• 03760124136319: Pediatric Right Angle ventricular catheter, Vision, 8 cm
• 03760124136302: Pediatric Right Angle ventricular catheter, Vision, 7 cm
• 03760124136296: Pediatric Right Angle ventricular catheter, Vision, 6 cm