ELUCENT MEDICAL, INC.

Address:7480 Flying Cloud Drive,Eden Prairie,MN,55344,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

Marker, Radiographic, Implantable (NEU) (10)

Premarket Exempt

Clear

EnVisio - 00851674008034 Catalog Number : ENVISIO-SYS

Device Description : EnVisio Navigation System: contains EnVisio Navigation Patient Pad and EnVisio N EnVisio Navigation System: contains EnVisio Navigation Patient Pad and EnVisio Navigation System Heads Up Display

Device Class : 2

Duns Number: 079322481

Premarket Exempt : No

Product Code : NEU

Prescription Use : Yes

Device Count : 1

EnVisio - 00851674008041 Catalog Number : NAV-PENCIL

Device Description : Envisio Navigator and Calibration Disk

Device Class : 2

Duns Number: 079322481

Premarket Exempt : No

Product Code : NEU

Prescription Use : Yes

Device Count : 1

EnVisio - 00851674008058 Catalog Number : ENVISIO-PP1

Device Description : Envisio Navigation Patient Pad

Device Class : 2

Duns Number: 079322481

Premarket Exempt : No

Product Code : NEU

Prescription Use : Yes

Device Count : 1

EnVisio - 00851674008065 Catalog Number : ENVISIO-HUD1

Device Description : EnVisio Navigation System Heads Up Display

Device Class : 2

Duns Number: 079322481

Premarket Exempt : No

Product Code : NEU

Prescription Use : Yes

Device Count : 1

EnVisio - 00851674008072 Catalog Number : NAV-SLIM

Device Description : Screenless version of the Envisio Navigator and Calibration Disk

Device Class : 2

Duns Number: 079322481

Premarket Exempt : No

Product Code : NEU

Prescription Use : Yes

Device Count : 1

EnVisio - 00851674008225 Catalog Number : ENVISIO-HUD2

Device Description : EnVisio Navigation System Heads Up Display

Device Class : 2

Duns Number: 079322481

Premarket Exempt : No

Product Code : NEU

Prescription Use : Yes

Device Count : 1

EnVisio - 10085167400822 Catalog Number : ENVISIO-HUD2

Device Description : EnVisio Navigation System Heads Up Display Version 2

Device Class : 2

Duns Number: 079322481

Premarket Exempt : No

Product Code : NEU

Prescription Use : Yes

Device Count : 1

SmartClip - 10851674008000 Catalog Number : SMARTCLIP-PINK-10

Device Description : Soft Tissue Marker and Delivery System - PINK

Device Class :

Duns Number: 079322481

Premarket Exempt : No

Product Code : NEU

Prescription Use : Yes

Device Count : 10

SmartClip - 10851674008017 Catalog Number : SMARTCLIP-GRN-10

Device Description : Soft Tissue Marker and Delivery System - GREEN

Device Class :

Duns Number: 079322481

Premarket Exempt : No

Product Code : NEU

Prescription Use : Yes

Device Count : 10

SmartClip - 10851674008024 Catalog Number : SMARTCLIP-PURP-10

Device Description : Soft Tissue Marker and Delivery System - PURPLE

Device Class :

Duns Number: 079322481

Premarket Exempt : No

Product Code : NEU

Prescription Use : Yes

Device Count : 10

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