Insight Medical Systems, Inc.

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

No

Clear

ARVIS ® - 00850012315001 Catalog Number :

Device Description : Instrument Tray Base

Device Class : 2

Duns Number: 080536842

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

ARVIS ® - 00850012315018 Catalog Number :

Device Description : Instrument Tray Lid

Device Class : 2

Duns Number: 080536842

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

ARVIS ® - 00850012315025 Catalog Number :

Device Description : ARVIS Hip and Knee Instrument Set

Device Class : 2

Duns Number: 080536842

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

ARVIS ® - 00850012315032 Catalog Number :

Device Description : Pin Caddy

Device Class : 2

Duns Number: 080536842

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

ARVIS ® - 00850012315049 Catalog Number :

Device Description : Pin Caddy Lid

Device Class : 2

Duns Number: 080536842

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

ARVIS ® - 00850012315056 Catalog Number :

Device Description : Registration Stylus

Device Class : 2

Duns Number: 080536842

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

ARVIS ® - 00850012315063 Catalog Number :

Device Description : Reference Mount

Device Class : 2

Duns Number: 080536842

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

ARVIS ® - 00850012315070 Catalog Number :

Device Description : Reference Tracker 1

Device Class : 2

Duns Number: 080536842

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

ARVIS ® - 00850012315087 Catalog Number :

Device Description : Tracker D

Device Class : 2

Duns Number: 080536842

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

ARVIS ® - 00850012315094 Catalog Number :

Device Description : Impactor V-Block Assembly

Device Class : 2

Duns Number: 080536842

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

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