Gc Orthodontics America Inc.

Address:3737 W. 127th Street,Alsip,IL,60803,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

BAND, ELASTIC, ORTHODONTIC (ECI) (10)

Premarket Exempt

Yes No

Clear

ELASTICS - E53585083111111 Catalog Number : 85-0831-1111

Device Description : ELASTICS MD 8MM 4OZ Clarinet 5/16 (NEON)

Device Class : 1

Duns Number: 063167128

Premarket Exempt : Yes

Product Code : ECI

Prescription Use : Yes

Device Count : 5000

ELASTICS - E53585084111111 Catalog Number : 85-0841-1111

Device Description : ELASTICS HV 8MM 6OZ Saxaphone 5/16(NEON)

Device Class : 1

Duns Number: 063167128

Premarket Exempt : Yes

Product Code : ECI

Prescription Use : Yes

Device Count : 5000

GC Ortho Chain - E53586101000001 Catalog Number : 86-1010-0000

Device Description : GC ORTHO CHAIN CLEAR SHORT 2M

Device Class : 1

Duns Number: 063167128

Premarket Exempt : Yes

Product Code : ECI

Prescription Use : Yes

Device Count : 1

GC Ortho Chain - E53586101000011 Catalog Number : 86-1010-0001

Device Description : GC ORTHO CHAIN Clear Short

Device Class : 1

Duns Number: 063167128

Premarket Exempt : Yes

Product Code : ECI

Prescription Use : Yes

Device Count : 1

GC Ortho Chain - E53586102000001 Catalog Number : 86-1020-0000

Device Description : GC ORTHO CHAIN CLEAR MEDIUM 2M

Device Class : 1

Duns Number: 063167128

Premarket Exempt : Yes

Product Code : ECI

Prescription Use : Yes

Device Count : 1

GC Ortho Chain - E53586102000011 Catalog Number : 86-1020-0001

Device Description : GC ORTHO CHAIN Clear Medium

Device Class : 1

Duns Number: 063167128

Premarket Exempt : Yes

Product Code : ECI

Prescription Use : Yes

Device Count : 1

GC Ortho Chain - E53586103000011 Catalog Number : 86-1030-0001

Device Description : GC ORTHO CHAIN Clear Long

Device Class : 1

Duns Number: 063167128

Premarket Exempt : Yes

Product Code : ECI

Prescription Use : Yes

Device Count : 1

GC Ortho Chain - E53586201000001 Catalog Number : 86-2010-0000

Device Description : GC ORTHO CHAIN GREY SHORT 2M

Device Class : 1

Duns Number: 063167128

Premarket Exempt : Yes

Product Code : ECI

Prescription Use : Yes

Device Count : 1

GC Ortho Chain - E53586201000011 Catalog Number : 86-2010-0001

Device Description : GC ORTHO CHAIN Grey Short

Device Class : 1

Duns Number: 063167128

Premarket Exempt : Yes

Product Code : ECI

Prescription Use : Yes

Device Count : 1

GC Ortho Chain - E53586202000001 Catalog Number : 86-2020-0000

Device Description : GC ORTHO CHAIN GREY MEDIUM 2M

Device Class : 1

Duns Number: 063167128

Premarket Exempt : Yes

Product Code : ECI

Prescription Use : Yes

Device Count : 1

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