Enova Illumination, Inc.

Address:6305 Sandburg Rd.,Minneapolis,MN,55427,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

Headlamp, Operating, Battery-Operated (HPP) (9) Loupe, Diagnostic/Surgical (FSP) (1)

Premarket Exempt

Yes

Clear

NA - 00850025993241 Catalog Number : 5460-700-040

Device Description : Quantum Deluxe Comfort Pad Set - 10 Pack

Device Class : 1

Duns Number: 080805136

Premarket Exempt : Yes

Product Code : HPP

Prescription Use : No

Device Count : 1

Enova Illumination - 00850025993258 Catalog Number : 99999-001

Device Description : LED Surgical Headlight Mounted on Headband with Battery Accessories

Device Class : 1

Duns Number: 080805136

Premarket Exempt : Yes

Product Code : HPP

Prescription Use : No

Device Count : 1

Enova Illumination - 00850025993265 Catalog Number : 99999-002

Device Description : Surgical Loupes

Device Class : 1

Duns Number: 080805136

Premarket Exempt : Yes

Product Code : FSP

Prescription Use : No

Device Count : 1

Enova Illumination - 00850025993272 Catalog Number : 99999-003

Device Description : Clip-on LED Light System with Battery Accessories

Device Class : 1

Duns Number: 080805136

Premarket Exempt : Yes

Product Code : HPP

Prescription Use : No

Device Count : 1

Enova Illumination - 00850025993289 Catalog Number :

Device Description : Axis Light

Device Class : 1

Duns Number: 080805136

Premarket Exempt : Yes

Product Code : HPP

Prescription Use : No

Device Count : 1

Enova Illumination - 00850025993296 Catalog Number :

Device Description : Axis Extension Battery Cable

Device Class : 1

Duns Number: 080805136

Premarket Exempt : Yes

Product Code : HPP

Prescription Use : No

Device Count : 1

Enova Illumination - 00850025993302 Catalog Number :

Device Description : PP Mobile Battery Charger

Device Class : 1

Duns Number: 080805136

Premarket Exempt : Yes

Product Code : HPP

Prescription Use : No

Device Count : 1

Enova Illumination - 00850025993319 Catalog Number :

Device Description : MagneLite

Device Class : 1

Duns Number: 080805136

Premarket Exempt : Yes

Product Code : HPP

Prescription Use : No

Device Count : 1

Enova Illumination - 00850025993326 Catalog Number :

Device Description : Atom Light Single Battery

Device Class : 1

Duns Number: 080805136

Premarket Exempt : Yes

Product Code : HPP

Prescription Use : No

Device Count : 1

Enova Illumination - 00850025993333 Catalog Number :

Device Description : Atom Light Charging Pad

Device Class : 1

Duns Number: 080805136

Premarket Exempt : Yes

Product Code : HPP

Prescription Use : No

Device Count : 1

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