VORTEX SURGICAL, LLC

Address:7626 East 88th Place,Indianapolis,IN,46256,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) (7) Hook, Ophthalmic (HNQ) (3)

Premarket Exempt

No Yes

Clear

27ga Soft Tip Cannula - B384VS02002719 Catalog Number : VS0200.27

Device Description : 27ga Soft Tip Cannula

Device Class : 1

Duns Number: 080375891

Premarket Exempt : Yes

Product Code : HMX

Prescription Use : No

Device Count : 1

Atraumatic Soft Tip - B384VS0210231 Catalog Number : VS0210.23

Device Description : 23ga Atraumatic Soft Tip

Device Class : 1

Duns Number: 080375891

Premarket Exempt : Yes

Product Code : HMX

Prescription Use : No

Device Count : 1

Atraumatic Soft Tip - B384VS0210251 Catalog Number : VS0210.25

Device Description : 25ga Atraumatic Soft Tip

Device Class : 1

Duns Number: 080375891

Premarket Exempt : Yes

Product Code : HMX

Prescription Use : No

Device Count : 1

Subretinal Injection Cannula - B384VS0220251 Catalog Number : VS0220.25

Device Description : Subretinal Injection Cannula for use with TPA

Device Class : 1

Duns Number: 080375891

Premarket Exempt : Yes

Product Code : HMX

Prescription Use : No

Device Count : 1

Versatile Soft Tip - B384VS0280231 Catalog Number : VS0280.23

Device Description : Extendable Soft Tip

Device Class : 1

Duns Number: 080375891

Premarket Exempt : Yes

Product Code : HMX

Prescription Use : No

Device Count : 1

Versatile Soft Tip - B384VS0280251 Catalog Number : VS0280.25

Device Description : Extendable Soft Tip

Device Class : 1

Duns Number: 080375891

Premarket Exempt : Yes

Product Code : HMX

Prescription Use : No

Device Count : 1

EDD - External Drainage and Depression Device - B384VS0290 Catalog Number : VS0290

Device Description : External Drainage and Depression

Device Class : 1

Duns Number: 080375891

Premarket Exempt : Yes

Product Code : HMX

Prescription Use : No

Device Count : 1

23ga Edge Advantage ILM Elevator - B384VS0300231 Catalog Number : VS300.23

Device Description : 23ga ILM elevator

Device Class : 1

Duns Number: 080375891

Premarket Exempt : Yes

Product Code : HNQ

Prescription Use : No

Device Count : 1

25ga Edge Advantage ILM Elevator - B384VS0300251 Catalog Number : VS0300.25

Device Description : 25ga ILM Elevator

Device Class : 1

Duns Number: 080375891

Premarket Exempt : Yes

Product Code : HNQ

Prescription Use : No

Device Count : 1

Retractable ILM Elevator - B384VS0350231 Catalog Number : VS0350.23

Device Description : 23ga Retractable ILM Elevator

Device Class : 1

Duns Number: 080375891

Premarket Exempt : Yes

Product Code : HNQ

Prescription Use : No

Device Count : 1

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