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) (9) Cystotome (HNY) (1)

Premarket Exempt

No Yes

Clear

MedOne - 10811313012003 Catalog Number : 3200

Device Description : Viscous Fluid Cannula 20g (4mm)

Device Class : 1

Duns Number: 004626680

Premarket Exempt : Yes

Product Code : HMX

Prescription Use : Yes

Device Count : 5

MedOne - 10811313012010 Catalog Number : 3201

Device Description : Viscous Fluid Cannula 20g (6mm)

Device Class : 1

Duns Number: 004626680

Premarket Exempt : Yes

Product Code : HMX

Prescription Use : Yes

Device Count : 5

MedOne - 10811313012027 Catalog Number : 3202

Device Description : Infusion Cannula 20g (4mm)

Device Class : 1

Duns Number: 004626680

Premarket Exempt : Yes

Product Code : HMX

Prescription Use : Yes

Device Count : 5

MedOne - 10811313012034 Catalog Number : 3203

Device Description : Infusion Cannula 20g (6mm)

Device Class : 1

Duns Number: 004626680

Premarket Exempt : Yes

Product Code : HMX

Prescription Use : Yes

Device Count : 5

MedOne - 10811313012041 Catalog Number : 3204

Device Description : MicroPick 25g

Device Class : 1

Duns Number: 004626680

Premarket Exempt : Yes

Product Code : HNY

Prescription Use : Yes

Device Count : 5

MedOne - 10811313012058 Catalog Number : 3205

Device Description : Cannula XL 20g

Device Class : 1

Duns Number: 004626680

Premarket Exempt : Yes

Product Code : HMX

Prescription Use : Yes

Device Count : 5

MedOne - 10811313012065 Catalog Number : 3206

Device Description : Cannula XL 23g

Device Class : 1

Duns Number: 004626680

Premarket Exempt : Yes

Product Code : HMX

Prescription Use : Yes

Device Count : 5

MedOne - 10811313012072 Catalog Number : 3207

Device Description : Cannula XL 25g

Device Class : 1

Duns Number: 004626680

Premarket Exempt : Yes

Product Code : HMX

Prescription Use : Yes

Device Count : 5

MedOne - 10811313012089 Catalog Number : 3208

Device Description : FlexTip™ Cannula XL 20g (3mm)

Device Class : 1

Duns Number: 004626680

Premarket Exempt : Yes

Product Code : HMX

Prescription Use : Yes

Device Count : 5

MedOne - 10811313012096 Catalog Number : 3209

Device Description : FlexTip™ Cannula XL 23g (3mm)

Device Class : 1

Duns Number: 004626680

Premarket Exempt : Yes

Product Code : HMX

Prescription Use : Yes

Device Count : 5

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