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

Photocoagulator And Accessories (HQB) (5) Powered Laser Surgical Instrument (GEX) (3) Cannula, Ophthalmic (HMX) (2)

Premarket Exempt

No Yes

Clear

23ga Flexible Tapered Laser Probe - Iridex Compatible - B384VS013023I1 Catalog Number : VS0130.23I

Device Description : 23ga Flexible Tapered Laser Probe - Iridex Compatible

Device Class : 2

Duns Number: 080375891

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

25ga Flexible Tapered Laser Probe - Alcon Compatible - B384VS013025A1 Catalog Number : VS0130.25A

Device Description : 25ga Flexible Tapered Laser Probe - Alcon Compatible

Device Class : 2

Duns Number: 080375891

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

25ga Flexible Tapered Laser Probe - Iridex Compatible - B384VS013025I1 Catalog Number : VS0130.25I

Device Description : 25ga Flexible Tapered Laser Probe - Iridex Compatible

Device Class : 2

Duns Number: 080375891

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

20ga Bending Laser Probe - Alcon Compatible - B384VS014020A1 Catalog Number : VS0140.20A

Device Description : 20ga Bending Laser Probe - Alcon Compatible

Device Class : 2

Duns Number: 080375891

Premarket Exempt : No

Product Code : HQB

Prescription Use : No

Device Count : 1

23ga Bending Laser Probe - Alcon Compatible - B384VS014023A1 Catalog Number : VS0140.23A

Device Description : 23ga Bending Laser Probe - Alcon Compatible

Device Class : 2

Duns Number: 080375891

Premarket Exempt : No

Product Code : HQB

Prescription Use : No

Device Count : 1

23ga Bending Laser Probe - Iridex Compatible - B384VS014023I1 Catalog Number : VS0140.23I

Device Description : 23ga Bending Laser Probe - Iridex Compatible

Device Class : 2

Duns Number: 080375891

Premarket Exempt : No

Product Code : HQB

Prescription Use : No

Device Count : 1

25ga Bending Laser Probe - Alcon Compatible - B384VS014025A1 Catalog Number : VS0140.25A

Device Description : 25ga Bending Laser Probe - Alcon Compatible

Device Class : 2

Duns Number: 080375891

Premarket Exempt : No

Product Code : HQB

Prescription Use : No

Device Count : 1

25ga Bending Laser Probe - Iridex Compatible - B384VS014025I1 Catalog Number : VS0140.25I

Device Description : 25ga Bending Laser Probe - Iridex Compatible

Device Class : 2

Duns Number: 080375891

Premarket Exempt : No

Product Code : HQB

Prescription Use : No

Device Count : 1

23ga Soft Tip Cannula - B384VS0200231 Catalog Number : VS0200.23

Device Description : 23ga Soft Tip Cannula

Device Class : 1

Duns Number: 080375891

Premarket Exempt : Yes

Product Code : HMX

Prescription Use : No

Device Count : 1

25ga Soft Tip Cannula - B384VS0200251 Catalog Number : VS0200.25

Device Description : 25ga Soft Tip Cannula

Device Class : 1

Duns Number: 080375891

Premarket Exempt : Yes

Product Code : HMX

Prescription Use : No

Device Count : 1

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