Synaptive Medical Inc

Address:555 Richmond Street West,Toronto Ontario,CA

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Neurological Stereotaxic Instrument (HAW) (9) System, Image Processing, Radiological (LLZ) (1)

Premarket Exempt

No Yes

Clear

Pointer Tool (SS) - 00670082000016 Catalog Number :

Device Class : 2

Duns Number: 203061833

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

BrightMatter Guide Calibration Block - 00670082000023 Catalog Number :

Device Class : 2

Duns Number: 203061833

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

Tracking Array for Brainpath - 00670082000030 Catalog Number :

Device Class :

Duns Number: 203061833

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

BrightMatter Patient Reference - 00670082000047 Catalog Number :

Device Class : 2

Duns Number: 203061833

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

BrightMatter Guide Sterilizable Storage Tray - 00670082000054 Catalog Number :

Device Class : 2

Duns Number: 203061833

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

BrightMatter Guide - 00670082000061 Catalog Number :

Device Class : 2

Duns Number: 203061833

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

BrightMatter Guide Software - 00670082000078 Catalog Number : SYN-0027

Device Class : 2

Duns Number: 203061833

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

BrightMatter Plan - 00670082000085 Catalog Number : SYN-0004

Device Class : 2

Duns Number: 203061833

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

BrightMatter Pointer - 00670082000092 Catalog Number :

Device Class : 2

Duns Number: 203061833

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

BrightMatter Pointer Sterilizable Storage Tray - 00670082000108 Catalog Number :

Device Class : 2

Duns Number: 203061833

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

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