NINEPOINT MEDICAL, INC.

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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

System, Imaging, Optical Coherence Tomography (Oct) (NQQ) (6)

Premarket Exempt

Clear

NvisionVLE Marking Upgrade Refurbished - 00859591006225 Catalog Number : 94301-M-UPG-R

Device Class : 2

Duns Number: 961880999

Premarket Exempt : No

Product Code : NQQ

Prescription Use : Yes

Device Count : 1

NvisionVLE Inflation Kit - 00859591006232 Catalog Number : 96101-60

Device Class :

Duns Number: 961880999

Premarket Exempt : No

Product Code : NQQ

Prescription Use : Yes

Device Count : 1

NvisionVLE Marking Console with IRIS - 00859591006249 Catalog Number : 94301-MI

Device Class : 2

Duns Number: 961880999

Premarket Exempt : No

Product Code : NQQ

Prescription Use : Yes

Device Count : 1

NvisionVLE Marking Console with IRIS, Refurbished - 00859591006256 Catalog Number : 94301-MI-R

Device Class : 2

Duns Number: 961880999

Premarket Exempt : No

Product Code : NQQ

Prescription Use : Yes

Device Count : 1

NvisionVLE Marking Console with IRIS, Upgraded - 00859591006263 Catalog Number :

Device Class : 2

Duns Number: 961880999

Premarket Exempt : No

Product Code : NQQ

Prescription Use : Yes

Device Count : 1

NvisionVLE Marking Console with IRIS, Upgraded, Refurbished - 00859591006270 Catalog Number :

Device Class : 2

Duns Number: 961880999

Premarket Exempt : No

Product Code : NQQ

Prescription Use : Yes

Device Count : 1

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