OCO BIOMEDICAL 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

Instruments, Dental Hand (DZN) (4)

Premarket Exempt

No Yes

Clear

SDI Driver - D785SDIMDS0 Catalog Number : MD-S

Device Description : 2.2/2.5mm SDI Driver (Short)Places both C&B and O-Ball 3.0 Implants

Device Class : 1

Duns Number: 094146123

Premarket Exempt : Yes

Product Code : DZN

Prescription Use : No

Device Count : 1

Surgical Driver - D785SURGICALDRIVER0 Catalog Number : SD

Device Description : Surgical Driver

Device Class : 1

Duns Number: 094146123

Premarket Exempt : Yes

Product Code : DZN

Prescription Use : No

Device Count : 1

Thumb Knob Wrench - D785THUMBKNOBWRENCH0 Catalog Number : TK

Device Description : Thumb Knob Wrench

Device Class : 1

Duns Number: 094146123

Premarket Exempt : Yes

Product Code : DZN

Prescription Use : No

Device Count : 1

Torque Wrench - D785TW61010 Catalog Number : 6101

Device Description : Torque Wrench (30-90 Ncm)

Device Class : 1

Duns Number: 094146123

Premarket Exempt : Yes

Product Code : DZN

Prescription Use : No

Device Count : 1

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