MONTERIS MEDICAL INC

Address:131 Cheshire Lane, Suite 100,Minnetonka,MN,55305,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

Powered Laser Surgical Instrument (GEX) (6) Coil, Magnetic Resonance, Specialty (MOS) (4)

Premarket Exempt

No Yes

Clear

AtamA™ System - 00816589020205 Catalog Number : ATB002-AS

Device Description : AtamA Patient Board

Device Class : 2

Duns Number: 021415875

Premarket Exempt : No

Product Code : MOS

Prescription Use : Yes

Device Count : 1

AtamA™ System - 00816589020212 Catalog Number : ATF103

Device Description : AtamA Head Fixation (3 piece)

Device Class : 2

Duns Number: 021415875

Premarket Exempt : No

Product Code : MOS

Prescription Use : Yes

Device Count : 1

AtamA™ System - 00816589020229 Catalog Number : ATB002-2

Device Description : AtamA Patient Board

Device Class : 2

Duns Number: 021415875

Premarket Exempt : No

Product Code : MOS

Prescription Use : Yes

Device Count : 1

AtamA™ System - 00816589020236 Catalog Number : ATF102

Device Description : AtamA Head Fixation (2 piece)

Device Class : 2

Duns Number: 021415875

Premarket Exempt : No

Product Code : MOS

Prescription Use : Yes

Device Count : 1

FullFire® Select Diffusing Tip Laser Probe - 00816589020243 Catalog Number : FFS002-01

Device Description : 2.2mm Diffusing Tip Laser Probe

Device Class : 2

Duns Number: 021415875

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

FullFire® Select Diffusing Tip Laser Probe - 00816589020250 Catalog Number : FFS000-01

Device Description : 2.2mm Diffusing Tip Laser Probe

Device Class : 2

Duns Number: 021415875

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

FullFire® Select Diffusing Tip Laser Probe - 00816589020267 Catalog Number : FFS122-01

Device Description : 2.2mm Diffusing Tip Laser Probe

Device Class : 2

Duns Number: 021415875

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

FullFire® Select Diffusing Tip Laser Probe - 00816589020274 Catalog Number : FFS222-01

Device Description : 2.2mm Diffusing Tip Laser Probe

Device Class : 2

Duns Number: 021415875

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

FullFire® Select Diffusing Tip Laser Probe - 00816589020281 Catalog Number : FFS322-01

Device Description : 2.2mm Diffusing Tip Laser Probe

Device Class : 2

Duns Number: 021415875

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

FullFire® Select Diffusing Tip Laser Probe - 00816589020298 Catalog Number : FFS422-01

Device Description : 2.2mm Diffusing Tip Laser Probe

Device Class : 2

Duns Number: 021415875

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

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