Insight Medical Systems, Inc.

Address:8601 Ranch Road 2222,Austin,TX,78730,US

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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) (10)

Premarket Exempt

Clear

ARVIS ® - 00850012315209 Catalog Number :

Device Description : Tracker C

Device Class : 2

Duns Number: 080536842

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

ARVIS ® - 00850012315216 Catalog Number :

Device Description : Femoral Reference Mount

Device Class : 2

Duns Number: 080536842

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

ARVIS ® - 00850012315223 Catalog Number :

Device Description : ARVIS Eyepiece

Device Class : 2

Duns Number: 080536842

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

ARVIS ® - 00850012315230 Catalog Number :

Device Description : ARVIS Belt Pack

Device Class : 2

Duns Number: 080536842

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

ARVIS ® - 00850012315247 Catalog Number :

Device Description : ARVIS Eyepiece Cable

Device Class : 2

Duns Number: 080536842

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

ARVIS ® - 00850012315254 Catalog Number :

Device Description : ARVIS Computer Module

Device Class : 2

Duns Number: 080536842

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

ARVIS ® - 00850012315261 Catalog Number :

Device Description : ARVIS Battery

Device Class : 2

Duns Number: 080536842

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

ARVIS ® - 00850012315278 Catalog Number :

Device Description : ARVIS Battery Charger

Device Class : 2

Duns Number: 080536842

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

ARVIS ® - 00850012315285 Catalog Number :

Device Description : ARVIS Charger Power Supply

Device Class : 2

Duns Number: 080536842

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

ARVIS ® - 00850012315292 Catalog Number :

Device Description : ARVIS Charger Cord, USA

Device Class : 2

Duns Number: 080536842

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

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