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) (10)

Premarket Exempt

Yes

Clear

AURADONICS - 00810033830006 Catalog Number :

Device Description : ELAST-O-TIES - GRAY, 1008 devices per package, see www.auradonics.com

Device Class : 1

Duns Number: 608537379

Premarket Exempt : Yes

Product Code : ECI

Prescription Use : Yes

Device Count : 1

AURADONICS - 00810033830013 Catalog Number :

Device Description : ELAST-O-TIES - MULTIPAK, 1008 devices per package, see www.auradonics.com

Device Class : 1

Duns Number: 608537379

Premarket Exempt : Yes

Product Code : ECI

Prescription Use : Yes

Device Count : 1

AURADONICS - 00810033830020 Catalog Number :

Device Description : ELAST-O-TIES - CLEAR, 1008 devices per package, see www.auradonics.com

Device Class : 1

Duns Number: 608537379

Premarket Exempt : Yes

Product Code : ECI

Prescription Use : Yes

Device Count : 1

AURADONICS - 00810033830037 Catalog Number :

Device Description : ELAST-O-TIES - PINK, 1008 devices per package, see www.auradonics.com

Device Class : 1

Duns Number: 608537379

Premarket Exempt : Yes

Product Code : ECI

Prescription Use : Yes

Device Count : 1

AURADONICS - 00810033830044 Catalog Number :

Device Description : ELAST-O-TIES - NEON GREEN, 1008 devices per package, see www.auradonics.com

Device Class : 1

Duns Number: 608537379

Premarket Exempt : Yes

Product Code : ECI

Prescription Use : Yes

Device Count : 1

AURADONICS - 00810033830051 Catalog Number :

Device Description : ELAST-O-TIES - PURPLE, 1008 devices per package, see www.auradonics.com

Device Class : 1

Duns Number: 608537379

Premarket Exempt : Yes

Product Code : ECI

Prescription Use : Yes

Device Count : 1

AURADONICS - 00810033830068 Catalog Number :

Device Description : ELAST-O-TIES - RED, 1008 devices per package, see www.auradonics.com

Device Class : 1

Duns Number: 608537379

Premarket Exempt : Yes

Product Code : ECI

Prescription Use : Yes

Device Count : 1

AURADONICS - 00810033830075 Catalog Number :

Device Description : ELAST-O-TIES - ROYAL BLUE, 1008 devices per package, see www.auradonics.com

Device Class : 1

Duns Number: 608537379

Premarket Exempt : Yes

Product Code : ECI

Prescription Use : Yes

Device Count : 1

AURADONICS - 00810033830082 Catalog Number :

Device Description : ELAST-O-TIES - BLACK, 1008 devices per package, see www.auradonics.com

Device Class : 1

Duns Number: 608537379

Premarket Exempt : Yes

Product Code : ECI

Prescription Use : Yes

Device Count : 1

AURADONICS - 00810033830099 Catalog Number :

Device Description : ELAST-O-TIES - ORANGE, 1008 devices per package, 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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