FDA.reportPublic FDA data

Short Pointer

Primary DI
00670082000269
Brand
Short Pointer
Company
Synaptive Medical Inc
Model
SYN-0559
Published
2023-01-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K183325000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K183325000Modus NavSynaptive Medical, Inc.2019-07-14HAW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00670082000269PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00670082000269006700820002696700820002690670082000269

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
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
203061833
Device count
1
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00670082000320Trackable Suction - Tube 6-M-30SYN-06762017-06-30
00670082000337Trackable Suction - Tube 8-M-30SYN-06772017-06-30
00670082000344Trackable Suction - Tube 10-M-30SYN-06782017-06-30
00670082000450EvrySYN-07772020-06-05
00670082000252Multi-Tool Calibration DeviceSYN-07552023-01-03
00670082000351Sterilizable Storage TraySYN-07542023-01-03
00670082000467Modus VSYN-09022020-06-05
00670082000474Modus VSYN-09032020-06-05
00670082000504Modus Nav Software2.1SYN-08672022-12-23
00670082000528Modus Nav Operator CartSYN-09822022-12-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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