FDA.reportPublic FDA data

Compass International

Primary DI
B169CYGSAP102A0
Brand
Compass International
Company
Compass International
Model
CYG-SAP-10-2A
Catalog number
CYG-SAP-10-2A
Device description
Cygnus-PFS Surgical Arm w/Detachable End
Published
2016-08-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HAWNeurological Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HAWNeurological Stereotaxic InstrumentNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B169CYGSAP102A0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Stereotactic neuronavigation/planning systemA mobile assembly of mains electricity (AC-powered) electronic and optical devices designed to receive and analyse patient magnetic resonance imaging (MRI) images and position landmarks manually or automatically on these images, then register the images by the mean of a three-dimensional (3-D) optical positioning system (frameless stereotactic neuronavigation) to provide real-time relative positioning for the treatment probes and instruments. It is typically used by healthcare providers in psychiatry, neuropsychiatry, and neurology for preoperative planning, in particular for consecutive image-guided transcranial magnetic stimulation (TMS) treatment sessions.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
809466410
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860009258129COMPASS CT Adaptation Stereotactic SystemPION-20CT-NBAR-102026-03-18
00860009258136COMPASS Stereotactic Retractor SystemPION-20RE-202026-03-18
00860009258105COMPASS CYGNUS-PFS IGS SystemCYG-PFSN-10TPCYG-PFSN-10TP2026-01-29
00860009258112COMPASS Stereotactic SystemPION-20PION-202026-01-29
B169RU1500Compass InternationalRU-150RU-1502016-08-26
B169RU3000Compass InternationalRU-300RU-3002016-08-26
B169CYGERG10D0Compass InternationalCYG-ERG-10DCYG-ERG-10D2016-08-12
B169CYG10B2TP0Compass InternationalCYG-10-B2TPCYG-10-B2TP2016-09-13
B169CYG10BTP0Compass InternationalCYG-10-BTPCYG-10-BTP2016-09-13
B169CYG10LPTP0Compass InternationalCYG-10-LPTPCYG-10-LPTP2016-09-13
B169CYG10LSTP0Compass InternationalCYG-10-LSTPCYG-10-LSTP2016-09-13
B169CYG10PTP0Compass InternationalCYG-10-PTPCYG-10-PTP2016-09-13
B169CYG10STP0Compass InternationalCYG-10-STPCYG-10-STP2016-09-13
B169CYG14FSCT100Compass InternationalCYG-14F-SCT10CYG-14F-SCT102016-09-13
B169CYG4FCT100Compass InternationalCYG-4F-CT10CYG-4F-CT102016-08-12
B169CYG4FCT10TP0Compass InternationalCYG-4F-CT10TPCYG-4F-CT10TP2016-09-13
B169CYG5FNPT100Compass InternationalCYG-5F-NPT10CYG-5F-NPT102016-09-13
B169CYG5FNPT10TP0Compass InternationalCYG-5F-NPT10TPCYG-5F-NPT10TP2016-09-13
B169CYG9FSCT100Compass InternationalCYG-9F-SCT10CYG-9F-SCT102016-09-13
B169CYG9FSCT10TP0Compass InternationalCYG-9F-SCT10TPCYG-9F-SCT10TP2016-09-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719878691024Nao Trac SBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878691208Foot ControllerBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878691246Display ScreenBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878691307USB MouseBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878691420Power Supply CordBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878691468Power Supply Cord (US) 5mBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878692021Surgical Equipment Drape PacksBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878693004Reference StylusBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878693042Tag SBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878693127Tag Support ArmBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878694001Instrument Registration Platform CoverBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695022Instrument Holder SBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695046Instrument Adaptor (3 mm)BRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695060Instrument Adaptor (4 mm)BRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695084Instrument Adaptor (5 mm)BRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695107Instrument Adaptor (8 mm)BRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695121SEEG AdaptorBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695145Catheter AdaptorBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695169Thumb Screw of Instrument HolderBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695183Set Screw of Instrument HolderBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695206Pin Screw of Instrument AdaptorBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695220Catheter Adaptor_3.5mmBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695244Instrument Adaptor (1.8 mm)BRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695268Instrument Adaptor (2 mm)BRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695282Instrument Adaptor (2.2 mm)BRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695305Instrument Adaptor (2.5 mm)BRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695329Instrument Adaptor (2.8 mm)BRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695343Instrument Adator (3.2 mm)BRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695367Instrument Adaptor (3.5 mm)BRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695381Instrument Adaptor (4.6 mm)BRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25