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) (10)

Premarket Exempt

Yes

Clear

NA - 00850025993142 Catalog Number : 5460-700-024

Device Description : Quasar Twist Cable

Device Class : 1

Duns Number: 080805136

Premarket Exempt : Yes

Product Code : HPP

Prescription Use : No

Device Count : 1

NA - 00850025993159 Catalog Number : 5460-700-021

Device Description : PP4 Power Pack Charging Base Station

Device Class : 1

Duns Number: 080805136

Premarket Exempt : Yes

Product Code : HPP

Prescription Use : No

Device Count : 1

NA - 00850025993166 Catalog Number : 5460-700-023

Device Description : Quantum Twist Cable

Device Class : 1

Duns Number: 080805136

Premarket Exempt : Yes

Product Code : HPP

Prescription Use : No

Device Count : 1

NA - 00850025993173 Catalog Number : 5460-700-011

Device Description : Quantum Cool LED Surgical Headlight

Device Class : 1

Duns Number: 080805136

Premarket Exempt : Yes

Product Code : HPP

Prescription Use : No

Device Count : 1

NA - 00850025993180 Catalog Number : 5460-700-010

Device Description : Quasar Warm LED Surgical Headlight

Device Class : 1

Duns Number: 080805136

Premarket Exempt : Yes

Product Code : HPP

Prescription Use : No

Device Count : 1

NA - 00850025993197 Catalog Number : 5460-700-009

Device Description : Quasar Cool LED Surgical Headlight

Device Class : 1

Duns Number: 080805136

Premarket Exempt : Yes

Product Code : HPP

Prescription Use : No

Device Count : 1

NA - 00850025993203 Catalog Number : 5460-700-012

Device Description : Quantum Warm LED Surgical Headlight

Device Class : 1

Duns Number: 080805136

Premarket Exempt : Yes

Product Code : HPP

Prescription Use : No

Device Count : 1

NA - 00850025993210 Catalog Number : 5460-700-037

Device Description : Quasar Standard Comfort Pad Set - 3 Pack

Device Class : 1

Duns Number: 080805136

Premarket Exempt : Yes

Product Code : HPP

Prescription Use : No

Device Count : 1

NA - 00850025993227 Catalog Number : 5460-700-038

Device Description : Quantum Deluxe Comfort Pad Set - 3 Pack

Device Class : 1

Duns Number: 080805136

Premarket Exempt : Yes

Product Code : HPP

Prescription Use : No

Device Count : 1

NA - 00850025993234 Catalog Number : 5460-700-039

Device Description : Quasar Standard Comfort Pad Set - 10 Pack

Device Class : 1

Duns Number: 080805136

Premarket Exempt : Yes

Product Code : HPP

Prescription Use : No

Device Count : 1

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