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) (6) Forceps, Ophthalmic (HNR) (2) Cannula, Ophthalmic (HMX) (1) Depressor, Orbital (HNX) (1)

Premarket Exempt

No Yes

Clear

ACTU8 End-Grip Forceps - B384VS074323 Catalog Number : VS0743.23

Device Description : ACTU8 End-Grip Forceps

Device Class : 1

Duns Number: 080375891

Premarket Exempt : Yes

Product Code : HNR

Prescription Use : No

Device Count : 1

ACTU8 End-Grip Forceps - B384VS074325 Catalog Number : VS0743.25

Device Description : ACTU8 End-Grip Forceps

Device Class : 1

Duns Number: 080375891

Premarket Exempt : Yes

Product Code : HNR

Prescription Use : No

Device Count : 1

TID - Todorich Illuminated Depressor - B384VS080016 Catalog Number : VS0800

Device Description : Illuminated Depressor Cap for light pipes

Device Class : 1

Duns Number: 080375891

Premarket Exempt : Yes

Product Code : HNX

Prescription Use : No

Device Count : 1

23ga Straight Laser Probe - VS01102319 Catalog Number : VS0110.23

Device Description : 23ga Straight Laser Probe

Device Class : 2

Duns Number: 080375891

Premarket Exempt : No

Product Code : HQB

Prescription Use : Yes

Device Count : 1

25ga Straight Laser Probe - VS01102517 Catalog Number : VS0110.25

Device Description : 25ga Straight Laser Probe

Device Class : 2

Duns Number: 080375891

Premarket Exempt : No

Product Code : HQB

Prescription Use : Yes

Device Count : 1

27ga Straight Laser Probe - VS01102719 Catalog Number : VS0110.27

Device Description : 27ga Straight Laser Probe

Device Class : 2

Duns Number: 080375891

Premarket Exempt : No

Product Code : HQB

Prescription Use : Yes

Device Count : 1

23ga Curved Laser Probe - VS01202316 Catalog Number : VS0120.23

Device Description : 23ga Curved Laser Probe

Device Class : 2

Duns Number: 080375891

Premarket Exempt : No

Product Code : HQB

Prescription Use : Yes

Device Count : 1

25ga Curved Laser Probe - VS01202518 Catalog Number : VS0120.25

Device Description : 25ga Curved Laser Probe

Device Class : 2

Duns Number: 080375891

Premarket Exempt : No

Product Code : HQB

Prescription Use : Yes

Device Count : 1

27ga Curved Laser Probe - VS0120271 Catalog Number : VS0120.27

Device Description : 27ga Curved Laser Probe

Device Class : 2

Duns Number: 080375891

Premarket Exempt : No

Product Code : HQB

Prescription Use : Yes

Device Count : 1

NANO SubRet Gateway Device - VS02251 Catalog Number : VS0225

Device Description : 28ga Delivery Device for transcleral procedures

Device Class : 1

Duns Number: 080375891

Premarket Exempt : Yes

Product Code : HMX

Prescription Use : No

Device Count : 1

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