AURADONICS INC.

AURADONICS 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

Band, Elastic, Orthodontic (ECI) (2)

Premarket Exempt

Yes

Clear

AURADONICS - 00810033838507 Catalog Number :

Device Description : LATEX-FREE ELASTICS 5/16" 2.5 oz. - NEON, 100000 ea., see www.auradonics.com

Device Class : 1

Duns Number: 608537379

Premarket Exempt : Yes

Product Code : ECI

Prescription Use : Yes

Device Count : 1

AURADONICS - 00810033838514 Catalog Number :

Device Description : LATEX-FREE ELASTICS 3/8" 2.5 oz. - NEON, 100000 ea., see www.auradonics.com

Device Class : 1

Duns Number: 608537379

Premarket Exempt : Yes

Product Code : ECI

Prescription Use : Yes

Device Count : 1

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