7D Surgical ULC

Address:60 Scarsdale Road, Unit 118,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

Orthopedic Stereotaxic Instrument (OLO) (6) Neurological Stereotaxic Instrument (HAW) (4)

Premarket Exempt

Clear

ENVISION 3D: IMAGE GUIDANCE SYSTEM - 00627843746614 Catalog Number :

Device Class : 2

Duns Number: 204326292

Premarket Exempt : No

Product Code : OLO

Prescription Use : No

Device Count : 1

ENVISION 3D: AWL - 00627843746621 Catalog Number :

Device Class : 2

Duns Number: 204326292

Premarket Exempt : No

Product Code : OLO

Prescription Use : No

Device Count : 1

ENVISION 3D: PEDICLE PROBE - 00627843746638 Catalog Number :

Device Class : 2

Duns Number: 204326292

Premarket Exempt : No

Product Code : OLO

Prescription Use : No

Device Count : 1

ENVISION 3D: REFERENCE CLAMP - 00627843746645 Catalog Number :

Device Class : 2

Duns Number: 204326292

Premarket Exempt : No

Product Code : OLO

Prescription Use : No

Device Count : 1

ENVISION 3D: Sterilization Tray - 00627843746652 Catalog Number :

Device Class : 2

Duns Number: 204326292

Premarket Exempt : No

Product Code : OLO

Prescription Use : No

Device Count : 1

ENVISION 3D: LIGHT HANDLE - 00627843746669 Catalog Number :

Device Class : 2

Duns Number: 204326292

Premarket Exempt : No

Product Code : OLO

Prescription Use : No

Device Count : 1

7D Surgical Cranial Reference Frame - 00627843746676 Catalog Number :

Device Class : 2

Duns Number: 204326292

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

7D Surgical Cranial Articulating Arm - 00627843746683 Catalog Number :

Device Class : 2

Duns Number: 204326292

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

7D Surgical Cranial Pointer - 00627843746690 Catalog Number :

Device Class : 2

Duns Number: 204326292

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

7D Surgical Cranial Sterilization Tray - 00627843746706 Catalog Number :

Device Class : 2

Duns Number: 204326292

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

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