FDA.reportPublic FDA data

Modus Nav Operator Cart

Primary DI
00670082000528
Brand
Modus Nav Operator Cart
Company
Synaptive Medical Inc
Model
SYN-0982
Published
2022-12-23
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
00670082000528PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00670082000528006700820005286700820005280670082000528

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
Serial number
true
Manufacturing 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
07340201503829Leksell Neurosurgical InstrumentsElekta Solutions ABHAW2026-10-20
07340201503836Leksell Neurosurgical InstrumentsElekta Solutions ABHAW2026-10-20
07340201503843Leksell Neurosurgical InstrumentsElekta Solutions ABHAW2026-10-20
07340201503850Leksell Neurosurgical InstrumentsElekta Solutions ABHAW2026-10-20
07340201503867Leksell Neurosurgical InstrumentsElekta Solutions ABHAW2026-10-20
07340201503812Leksell Neurosurgical InstrumentsElekta Solutions ABHAW2026-10-19
06974813832681NASinovation (Beijing) Medical Technology Co., LtdHAW2026-09-29
06974813832698NASinovation (Beijing) Medical Technology Co., LtdHAW2026-09-29
06974813832704NASinovation (Beijing) Medical Technology Co., LtdHAW2026-09-29
06974813832711NASinovation (Beijing) Medical Technology Co., LtdHAW2026-09-29
06974813832728NASinovation (Beijing) Medical Technology Co., LtdHAW2026-09-29
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06974813832759NASinovation (Beijing) Medical Technology Co., LtdHAW2026-09-29
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06974813832773NASinovation (Beijing) Medical Technology Co., LtdHAW2026-09-29
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06974813832834NASinovation (Beijing) Medical Technology Co., LtdHAW2026-09-29
06974813832841NASinovation (Beijing) Medical Technology Co., LtdHAW2026-09-29
00889024713895ROSA ONE BRAIN APPLICATION (US)MEDTECHHAW2026-09-28
00889024714113PLANNING STATION - USAMEDTECHHAW2026-09-28
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00850088866001CBYONMED-SURGICAL SERVICES, INC.HAW2026-09-25
00199150054404ZEISS TIVATO 700MEDTRONIC NAVIGATION, INC.HAW2026-09-21
00199150054442ZEISS PENTERO 800SMEDTRONIC NAVIGATION, INC.HAW2026-09-21