ASI MEDICAL, INC.

Address:8811 AMERICAN WAY STE 130,ENGLEWOOD,CO,80112,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

Unit, Operative Dental (EIA) (10)

Premarket Exempt

No Yes

Clear

N/A - 00850309007008 Catalog Number : 90-1044

Device Description : Classic Assistant's System

Device Class : 1

Duns Number: 808695159

Premarket Exempt : Yes

Product Code : EIA

Prescription Use : No

Device Count : 1

N/A - 00850309007015 Catalog Number : 90-1045

Device Description : Classic Assistant's System

Device Class : 1

Duns Number: 808695159

Premarket Exempt : Yes

Product Code : EIA

Prescription Use : No

Device Count : 1

N/A - 00850309007022 Catalog Number : 90-2045

Device Description : Classic Dental System

Device Class : 1

Duns Number: 808695159

Premarket Exempt : No

Product Code : EIA

Prescription Use : No

Device Count : 1

N/A - 00850309007039 Catalog Number : 90-1050

Device Description : Designer Assistant's System

Device Class : 1

Duns Number: 808695159

Premarket Exempt : Yes

Product Code : EIA

Prescription Use : No

Device Count : 1

N/A - 00850309007046 Catalog Number : 90-1054

Device Description : Designer Assistant's System

Device Class : 1

Duns Number: 808695159

Premarket Exempt : Yes

Product Code : EIA

Prescription Use : No

Device Count : 1

N/A - 00850309007053 Catalog Number : 90-2054

Device Description : Designer Dental System

Device Class : 1

Duns Number: 808695159

Premarket Exempt : No

Product Code : EIA

Prescription Use : No

Device Count : 1

Triton - 00850309007060 Catalog Number : 90-1046

Device Description : Triton Assistant’s System

Device Class : 1

Duns Number: 808695159

Premarket Exempt : No

Product Code : EIA

Prescription Use : No

Device Count : 1

Triton - 00850309007077 Catalog Number : 90-2005

Device Description : Triton Dental System

Device Class : 1

Duns Number: 808695159

Premarket Exempt : Yes

Product Code : EIA

Prescription Use : No

Device Count : 1

Triton - 00850309007084 Catalog Number : 90-2046

Device Description : Triton Dental System

Device Class : 1

Duns Number: 808695159

Premarket Exempt : No

Product Code : EIA

Prescription Use : No

Device Count : 1

Triton - 00850309007091 Catalog Number : 90-2015

Device Description : Triton Dental System

Device Class : 1

Duns Number: 808695159

Premarket Exempt : No

Product Code : EIA

Prescription Use : No

Device Count : 1

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