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) Syringe, Piston (FMF) (1)

Premarket Exempt

No Yes

Clear

MedOne - 10811313012744 Catalog Number : 3274

Device Description : Visco Dissection Cannula 25g

Device Class : 1

Duns Number: 004626680

Premarket Exempt : Yes

Product Code : HMX

Prescription Use : Yes

Device Count : 1

MedOne - 10811313012751 Catalog Number : 3275

Device Description : MicroDose™ Injector

Device Class : 2

Duns Number: 004626680

Premarket Exempt : No

Product Code : FMF

Prescription Use : Yes

Device Count : 5

MedOne - 10811313012768 Catalog Number : 3276

Device Description : Backflush Cannula 27g

Device Class : 1

Duns Number: 004626680

Premarket Exempt : Yes

Product Code : HMX

Prescription Use : Yes

Device Count : 5

MedOne - 10811313012782 Catalog Number : 3278

Device Description : Backflush FlexTip™ 27g

Device Class : 1

Duns Number: 004626680

Premarket Exempt : Yes

Product Code : HMX

Prescription Use : Yes

Device Count : 5

MedOne - 10811313012799 Catalog Number : 3279

Device Description : Extendable FlexTip™ Cannula 20g

Device Class : 1

Duns Number: 004626680

Premarket Exempt : Yes

Product Code : HMX

Prescription Use : Yes

Device Count : 5

MedOne - 10811313012867 Catalog Number : 3286

Device Description : Backflush Cannula 23g

Device Class : 1

Duns Number: 004626680

Premarket Exempt : Yes

Product Code : HMX

Prescription Use : Yes

Device Count : 5

MedOne - 10811313012904 Catalog Number : 3290

Device Description : Backflush FlexTip™ 23g

Device Class : 1

Duns Number: 004626680

Premarket Exempt : Yes

Product Code : HMX

Prescription Use : Yes

Device Count : 5

MedOne - 10811313012959 Catalog Number : 3295

Device Description : Backflush Cannula 25g

Device Class : 1

Duns Number: 004626680

Premarket Exempt : Yes

Product Code : HMX

Prescription Use : Yes

Device Count : 5

MedOne - 10811313012966 Catalog Number : 3296

Device Description : Backflush FlexTip™ 25g

Device Class : 1

Duns Number: 004626680

Premarket Exempt : Yes

Product Code : HMX

Prescription Use : Yes

Device Count : 5

MedOne - 10811313012980 Catalog Number : 3298

Device Description : Extendable FlexTip™ Cannula 25g

Device Class : 1

Duns Number: 004626680

Premarket Exempt : Yes

Product Code : HMX

Prescription Use : Yes

Device Count : 5

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