Compass International REG-3002

GUDID B169REG30020

Radiographic Markers - Large Disc

Compass International

Imaging lesion localization marker, external, single-use

• Primary Device ID: B169REG30020
• NIH Device Record Key: c9073097-0e12-4139-8b8e-8f02da086487
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Compass International
• Version Model Number: REG-3002
• Catalog Number: REG-3002
• Company DUNS: 809466410
• Company Name: Compass International
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B169REG30020 [Primary]

FDA Product Code

• HAW: Neurological Stereotaxic Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-08-26

On-Brand Devices [Compass International]

• B169VS300: Vertical Support with Base Fixation
• B169TP300: Cygnus Test Phantom
• B169TP100: Chambered Test Phantom (Frame)
• B169SST100: Sundt Stereotaxic Suction Tip
• B169SS100: Storage Stand
• B169SP200: Sharp Pins (titanium) w/collets
• B169SOFTWARE0: Software Maintenance Contract
• B169SLS100: Slide Locking Screw
• B169RU3000: 300 MM Ruler
• B169RU1500: 150 MM Ruler
• B169RFS100: Remote Foot Switch
• B169REGBCBAY0: Regulus Bayonette Tip (30 degree)
• B169REG30D0: Regulus Pointer Tip
• B169REG30BCENT0: Regulus Long Suction (ENT)
• B169REG30BC0: Regulus Suction TIp - Center
• B169REG30020: Radiographic Markers - Large Disc
• B169PWRTRAY0: Stainless Steel Line Conditioner Bracket
• B169PLS100: Plastic Sleeve with Nut - Short White
• B169PLL100: Plastic Sleeve w/Nut - Long / Black
• B169PLES100: Plastic Sleeve with Nut - Extra Short Tan
• B169PLEL100: Plastic Sleeve w/Nut - Extra Long Grey
• B169KCP200: Kelly Coagulation Probe
• B169FP100: Carbon Fiber Pins
• B169DBNS30100: Short Disposable Biopsy Needle w/Removable Depth Stop
• B169DBNPS3010T0: Short Disposable 10mm Biopsy Needle w/Movable Depth Stop & Tracker
• B169DBNP3010S0: Long Disposable Biopsy Needle w/Fixed Stainless Steel Depth Stop
• B169DBNP1010TP0: Cygnus-PFS TracPlus Disposable Biopsy Needle
• B169DBN30100: Disposable Biopsy Needle Removable Depth Stop
• B169CYGSAP102A0: Cygnus-PFS Surgical Arm w/Detachable End
• B169CYGERG10D0: Ergotron Transmitter Mount
• B169CYG9FSCT10TP0: Cygnus-PFS TracPlus 9F Slit Catheter Tracker
• B169CYG9FSCT100: Cygnus-PFS 9F Slit Catheter Tracker
• B169CYG5FNPT10TP0: TracPlus 5F Needle Pointer Tracker
• B169CYG5FNPT100: Cygnus-PFS 5F Needle Point Tracker
• B169CYG4FCT10TP0: TracPlus 4F Catheter Tracker
• B169CYG4FCT100: Cygnus-PFS 4F Catheter Tracker
• B169CYG14FSCT100: Slit 14 French Catheter Tracker
• B169CYG10STP0: TracPlus Short Suction Tip
• B169CYG10PTP0: TracPlus Pointer Tip
• B169CYG10LSTP0: TracPlus Long Suction
• B169CYG10LPTP0: Cygnus TracPlus Long Pointer
• B169CYG10BTP0: TracPlus Bayonette Suction
• B169CYG10B2TP0: TracPlus Straight Offset Bayonette
• B169CW200: Collet Wrench
• B16963MRL0: Micrometer for measuring Carbon Fiber Pins on Head Frame