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) Knife, Ophthalmic (HNN) (4)

Premarket Exempt

No Yes

Clear

MedOne - 10811313012607 Catalog Number : 3260

Device Description : FlexTip™ Cannula 27g (0.75mm)

Device Class : 1

Duns Number: 004626680

Premarket Exempt : Yes

Product Code : HMX

Prescription Use : Yes

Device Count : 5

MedOne - 10811313012614 Catalog Number : 3261

Device Description : MicroTip Beveled Cannula 25g/40g

Device Class : 1

Duns Number: 004626680

Premarket Exempt : Yes

Product Code : HMX

Prescription Use : Yes

Device Count : 1

MedOne - 10811313012621 Catalog Number : 3262

Device Description : PolyTip® Cannula 25g/33g (2mm)

Device Class : 1

Duns Number: 004626680

Premarket Exempt : Yes

Product Code : HMX

Prescription Use : Yes

Device Count : 5

MedOne - 10811313012638 Catalog Number : 3263

Device Description : Nano Cannula 25g/48g

Device Class : 1

Duns Number: 004626680

Premarket Exempt : Yes

Product Code : HMX

Prescription Use : Yes

Device Count : 1

MedOne - 10811313012645 Catalog Number : 3264

Device Description : FlexTip™ Brush 27g

Device Class : 1

Duns Number: 004626680

Premarket Exempt : Yes

Product Code : HMX

Prescription Use : Yes

Device Count : 5

MedOne - 10811313012669 Catalog Number : 3266

Device Description : AdvantEdge® MVR Knife 20g

Device Class : 1

Duns Number: 004626680

Premarket Exempt : Yes

Product Code : HNN

Prescription Use : Yes

Device Count : 5

MedOne - 10811313012683 Catalog Number : 3268

Device Description : AdvantEdge® MVR Knife 23g

Device Class : 1

Duns Number: 004626680

Premarket Exempt : Yes

Product Code : HNN

Prescription Use : Yes

Device Count : 5

MedOne - 10811313012690 Catalog Number : 3269

Device Description : AdvantEdge® MVR Knife 23g (Angled)

Device Class : 1

Duns Number: 004626680

Premarket Exempt : Yes

Product Code : HNN

Prescription Use : Yes

Device Count : 5

MedOne - 10811313012720 Catalog Number : 3272

Device Description : AdvantEdge® MVR Knife 23g (Narrow)

Device Class : 1

Duns Number: 004626680

Premarket Exempt : Yes

Product Code : HNN

Prescription Use : Yes

Device Count : 5

MedOne - 10811313012737 Catalog Number : 3273

Device Description : VFI Cannula 27g

Device Class : 1

Duns Number: 004626680

Premarket Exempt : Yes

Product Code : HMX

Prescription Use : Yes

Device Count : 5

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