MEDONE SURGICAL INC

Address:670 TALLEVAST ROAD,SARASOTA,FL,34243,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

Cannula, Ophthalmic (HMX) (6)

Premarket Exempt

No Yes

Clear

MedOne - 10811313014236 Catalog Number : 3423

Device Description : DualBore SideFlo® Cannula 23g

Device Class : 1

Duns Number: 004626680

Premarket Exempt : Yes

Product Code : HMX

Prescription Use : Yes

Device Count : 5

MedOne - 10811313014250 Catalog Number : 3425

Device Description : DualBore SideFlo® Cannula 25g

Device Class : 1

Duns Number: 004626680

Premarket Exempt : Yes

Product Code : HMX

Prescription Use : Yes

Device Count : 5

MedOne - 10811313014274 Catalog Number : 3427

Device Description : DualBore SideFlo® Cannula 27g

Device Class : 1

Duns Number: 004626680

Premarket Exempt : Yes

Product Code : HMX

Prescription Use : Yes

Device Count : 5

MedOne - 10811313015066 Catalog Number : 3506

Device Description : Backflush Reservoir Replacement

Device Class : 1

Duns Number: 004626680

Premarket Exempt : Yes

Product Code : HMX

Prescription Use : Yes

Device Count : 5

MedOne - 10811313015073 Catalog Number : 3507

Device Description : Extendable PolyTip® Cannula 25g/38g [Shiraga]

Device Class : 1

Duns Number: 004626680

Premarket Exempt : Yes

Product Code : HMX

Prescription Use : Yes

Device Count : 5

MedOne - 10811313015080 Catalog Number : 3508

Device Description : Extendable FlexTip™ Brush 25g

Device Class : 1

Duns Number: 004626680

Premarket Exempt : Yes

Product Code : HMX

Prescription Use : Yes

Device Count : 5

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