FDA.reportPublic FDA data

Tracking Array for Brainpath

Primary DI
00670082000030
Brand
Tracking Array for Brainpath
Company
Synaptive Medical Inc
Model
SYN-0015
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HAWNeurological Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HAWNeurological Stereotaxic InstrumentNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K153281000
K183325000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153281000BrightMatter Guide with Surface Trace RegistrationSynaptive Medical, Inc.2016-03-30HAW
K183325000Modus NavSynaptive Medical, Inc.2019-07-14HAW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10670082000037PackageGS110In Commercial Distribution
00670082000030PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1067008200003710670082000037
00670082000030006700820000306700820000300670082000030

GMDN Terms#

Term, Definition table
TermDefinition
Neurological stereotactic surgery systemAn assembly of devices that typically consists of a rigid frame, positioning and alignment components, workstation, and a calibrated guide mechanism for precisely positioning probes, other instruments, or implantable devices during neurosurgery. The system may include computerized functions to store diagnostic images used for image-guided surgery.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
203061833
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00670082000610Modus Plan2.2SYN-08662025-01-17
00670082000511Modus Plan2.1SYN-08662022-12-13
00670082000443Modus Plan2.0SYN-08662019-08-06
00670082000085BrightMatter Plan1.3SYN-00042016-09-24
00670082000115ImageDrive Clinical1.1SYN-05782016-09-24
00670082000122ImageDrive Pro1.1SYN-06272017-08-16
00670082000139ClearCanvas Personal Edition Workstation13.1SYN-05242017-08-16
00670082000160BrightMatter Plan1.4SYN-00042016-11-11
00670082000368BrightMatter Plan1.5SYN-00042018-09-28
00670082000412BrightMatter Plan1.6SYN-08662018-09-28
00670082000153Trackable Suction - Tube 6-L-30SYN-06512017-02-28
00670082000214Trackable Suction - Tube 12-L-30SYN-06532017-02-28
00670082000221Trackable Suction - Tube 6-L-90SYN-06542017-02-28
00670082000238Trackable Suction - Tube 10-L-90SYN-06552017-02-28
00670082000245Trackable Suction - Tube 12-L-90SYN-06562017-02-28
00670082000276Trackable Suction - Tube 4-S-30SYN-06712017-06-30
00670082000283Trackable Suction - Tube 6-S-30SYN-06722017-06-30
00670082000290Trackable Suction - Tube 8-S-30SYN-06732017-06-30
00670082000306Trackable Suction - Tube 10-S-30SYN-06742017-06-30
00670082000313Trackable Suction - Tube 4-M-30SYN-06752017-06-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199150071968Stealth AXiS Leica KitMEDTRONIC NAVIGATION, INC.HAW2026-09-25
00199150071975Stealth AXiS Kinevo 900 KitMEDTRONIC NAVIGATION, INC.HAW2026-09-25
00199150071982Stealth AXiS Pentero 900 KitMEDTRONIC NAVIGATION, INC.HAW2026-09-25
00850088866001CBYONMED-SURGICAL SERVICES, INC.HAW2026-09-25
00199150054404ZEISS TIVATO 700MEDTRONIC NAVIGATION, INC.HAW2026-09-21
00199150054442ZEISS PENTERO 800SMEDTRONIC NAVIGATION, INC.HAW2026-09-21
07340201503683Leksell Vantage Stereotactic SystemElekta Solutions ABHAW2026-08-18
07340201503713Leksell Vantage Stereotactic SystemElekta Solutions ABHAW2026-08-18
07340201503720Leksell Vantage Stereotactic SystemElekta Solutions ABHAW2026-08-18
07340201503744Leksell Vantage Stereotactic SystemElekta Solutions ABHAW2026-08-18
07340201503768Leksell Vantage Stereotactic SystemElekta Solutions ABHAW2026-08-18
07340201503942Leksell Vantage Stereotactic SystemElekta Solutions ABHAW2026-08-18
07340201503959Leksell Vantage Stereotactic SystemElekta Solutions ABHAW2026-08-18
00763000994587Stealth AXiS™ GEHC CRANIAL INTEGRATION KIT Stainless SteelMEDTRONIC NAVIGATION, INC.HAW2026-08-17
00199150067664Stealth AXiS™ GEHC CRANIAL INTEGRATION KITMEDTRONIC NAVIGATION, INC.HAW2026-08-15
00763000989958Stealth AXiS™ GEHC Craniotomy Transducer TrackerMEDTRONIC NAVIGATION, INC.HAW2026-08-15
00763000989965Stealth AXiS™ GEHC craniotomy Transducer Verification DeviceMEDTRONIC NAVIGATION, INC.HAW2026-08-15
00199150054466N/AMEDTRONIC NAVIGATION, INC.HAW2026-08-08
00763000381141N/AMEDTRONIC NAVIGATION, INC.HAW2026-08-08
00199150054398StealthStation S8MEDTRONIC NAVIGATION, INC.HAW2026-08-07
G076A900687A0Localite TMS Navigator TSLOCALITE GmbHHAW2026-08-03
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