VORTEX SURGICAL, LLC

Address:7626 East 88th Place,Indianapolis,IN,46256,US

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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

Powered Laser Surgical Instrument (GEX) (9) Cannula, Ophthalmic (HMX) (1)

Premarket Exempt

No Yes

Clear

25ga Soft Tip Cannula - Bulk - B3842002517 Catalog Number : VS0200.25B

Device Description : Bulk (100) 25ga Soft Tip Cannula

Device Class : 1

Duns Number: 080375891

Premarket Exempt : Yes

Product Code : HMX

Prescription Use : No

Device Count : 1

20ga Straight Laser Probe - Alcon compatible - B384VS011020A1 Catalog Number : VS0110.20A

Device Description : 20ga Straight Laser Probe - Alcon compatible

Device Class : 2

Duns Number: 080375891

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

23ga Straight Laser Probe - Alcon Compatible - B384VS011023A1 Catalog Number : VS0110.25A

Device Description : 23ga Straight Laser Probe - Alcon Compatible

Device Class : 2

Duns Number: 080375891

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

25ga Straight Laser Probe - Alcon Compatible - B384VS011025A1 Catalog Number : VS0110.25A

Device Description : 25ga Straight Laser Probe - Alcon Compatible

Device Class : 2

Duns Number: 080375891

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

20ga Curved Laser Probe - Alcon Compatible - B384VS012020A1 Catalog Number : VS0120.20A

Device Description : 20ga Curved Laser Probe- Alcon Compatible

Device Class : 2

Duns Number: 080375891

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

25ga Curved Laser Probe - Alcon Compatible - B384VS012025A1 Catalog Number : VS120.25A

Device Description : 25ga Curved Laser Probe - Alcon Compatible

Device Class : 2

Duns Number: 080375891

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

27ga Curved Laser Probe - Alcon Compatible - B384VS012027A1 Catalog Number : VS0120.27A

Device Description : 27ga Curved Laser Probe - Alcon Compatible

Device Class : 2

Duns Number: 080375891

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

27ga Curved Laser Probe - Iridex Compatible - B384VS012027I1 Catalog Number : VS0120.27I

Device Description : 27ga Curved Laser Probe - Iridex Compatible

Device Class : 2

Duns Number: 080375891

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

20ga Flexible Tapered Laser Probe - Alcon Compatible - B384VS013020A1 Catalog Number : VS0130.20A

Device Description : 20ga Flexible Tapered Laser Probe - Alcon Compatible

Device Class : 2

Duns Number: 080375891

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

23ga Flexible Tapered Laser Probe - Alcon Compatible - B384VS013023A1 Catalog Number : VS0130.23A

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

Device Class : 2

Duns Number: 080375891

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

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