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) (10)

Premarket Exempt

No Yes

Clear

MedOne - 10811313012355 Catalog Number : 3235

Device Description : VFI Cannula 23g

Device Class : 1

Duns Number: 004626680

Premarket Exempt : Yes

Product Code : HMX

Prescription Use : Yes

Device Count : 5

MedOne - 10811313012379 Catalog Number : 3237

Device Description : Dual Bore Cannula 20g

Device Class : 1

Duns Number: 004626680

Premarket Exempt : Yes

Product Code : HMX

Prescription Use : Yes

Device Count : 5

MedOne - 10811313012386 Catalog Number : 3238

Device Description : FlexTip™ Cannula 20g (1mm)

Device Class : 1

Duns Number: 004626680

Premarket Exempt : Yes

Product Code : HMX

Prescription Use : Yes

Device Count : 5

MedOne - 10811313012393 Catalog Number : 3239

Device Description : Dual Bore Cannula 23g

Device Class : 1

Duns Number: 004626680

Premarket Exempt : Yes

Product Code : HMX

Prescription Use : Yes

Device Count : 5

MedOne - 10811313012409 Catalog Number : 3240

Device Description : Dual Bore Cannula 25g

Device Class : 1

Duns Number: 004626680

Premarket Exempt : Yes

Product Code : HMX

Prescription Use : Yes

Device Count : 5

MedOne - 10811313012416 Catalog Number : 3241

Device Description : PolyTip® VFI Cannula 23g (10mm)

Device Class : 1

Duns Number: 004626680

Premarket Exempt : Yes

Product Code : HMX

Prescription Use : Yes

Device Count : 5

MedOne - 10811313012423 Catalog Number : 3242

Device Description : FlexTip™ Cannula 23g (5mm)

Device Class : 1

Duns Number: 004626680

Premarket Exempt : Yes

Product Code : HMX

Prescription Use : Yes

Device Count : 5

MedOne - 10811313012430 Catalog Number : 3243

Device Description : High Pressure Extension Tube

Device Class : 1

Duns Number: 004626680

Premarket Exempt : Yes

Product Code : HMX

Prescription Use : Yes

Device Count : 5

MedOne - 10811313012454 Catalog Number : 3245

Device Description : VFI Infusion Cannula 25g

Device Class : 1

Duns Number: 004626680

Premarket Exempt : Yes

Product Code : HMX

Prescription Use : Yes

Device Count : 5

MedOne - 10811313012461 Catalog Number : 3246

Device Description : VFI Infusion Cannula 23g

Device Class : 1

Duns Number: 004626680

Premarket Exempt : Yes

Product Code : HMX

Prescription Use : Yes

Device Count : 5

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