27ga Curved Laser Probe - Iridex Compatible VS0120.27I

GUDID B384012027I5

27ga Curved Laser Probe - Iridex Compatible

VORTEX SURGICAL, LLC

Ophthalmic laser system beam guide Ophthalmic laser system beam guide Ophthalmic laser system beam guide Ophthalmic laser system beam guide Ophthalmic laser system beam guide Ophthalmic laser system beam guide Ophthalmic laser system beam guide Ophthalmic laser system beam guide Ophthalmic laser system beam guide Ophthalmic laser system beam guide Ophthalmic laser system beam guide Ophthalmic laser system beam guide Ophthalmic laser system beam guide Ophthalmic laser system beam guide Ophthalmic laser system beam guide Ophthalmic laser system beam guide Ophthalmic laser system beam guide
Primary Device IDB384012027I5
NIH Device Record Key7229cd06-1f05-41b5-873d-b1b83a203dbd
Commercial Distribution StatusIn Commercial Distribution
Brand Name27ga Curved Laser Probe - Iridex Compatible
Version Model NumberVS0120.27I
Catalog NumberVS0120.27I
Company DUNS080375891
Company NameVORTEX SURGICAL, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone636-778-4350
Emailinfo@vortexsurgical.com
Phone636-778-4350
Emailinfo@vortexsurgical.com
Phone636-778-4350
Emailinfo@vortexsurgical.com
Phone636-778-4350
Emailinfo@vortexsurgical.com
Phone636-778-4350
Emailinfo@vortexsurgical.com
Phone636-778-4350
Emailinfo@vortexsurgical.com
Phone636-778-4350
Emailinfo@vortexsurgical.com
Phone636-778-4350
Emailinfo@vortexsurgical.com
Phone636-778-4350
Emailinfo@vortexsurgical.com
Phone636-778-4350
Emailinfo@vortexsurgical.com
Phone636-778-4350
Emailinfo@vortexsurgical.com
Phone636-778-4350
Emailinfo@vortexsurgical.com
Phone636-778-4350
Emailinfo@vortexsurgical.com
Phone636-778-4350
Emailinfo@vortexsurgical.com
Phone636-778-4350
Emailinfo@vortexsurgical.com
Phone636-778-4350
Emailinfo@vortexsurgical.com
Phone636-778-4350
Emailinfo@vortexsurgical.com

Device Dimensions

Needle Gauge27 Gauge
Needle Gauge27 Gauge
Needle Gauge27 Gauge
Needle Gauge27 Gauge
Needle Gauge27 Gauge
Needle Gauge27 Gauge
Needle Gauge27 Gauge
Needle Gauge27 Gauge
Needle Gauge27 Gauge
Needle Gauge27 Gauge
Needle Gauge27 Gauge
Needle Gauge27 Gauge
Needle Gauge27 Gauge
Needle Gauge27 Gauge
Needle Gauge27 Gauge
Needle Gauge27 Gauge
Needle Gauge27 Gauge

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB384012027I5 [Package]
Contains: B384VS012027I1
Package: Box [10 Units]
In Commercial Distribution
HIBCCB384VS012027I1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

Devices Manufactured by VORTEX SURGICAL, LLC

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VS01102517 - 25ga Straight Laser Probe2020-02-06 25ga Straight Laser Probe
VS01102719 - 27ga Straight Laser Probe2020-02-06 27ga Straight Laser Probe
VS01202316 - 23ga Curved Laser Probe2020-02-06 23ga Curved Laser Probe
VS01202518 - 25ga Curved Laser Probe2020-02-06 25ga Curved Laser Probe
VS02251 - NANO SubRet Gateway Device2020-01-31 28ga Delivery Device for transcleral procedures
B384VS05001 - I² Kit for intraocular injection2019-11-08 Intraocular Injection Kit - contains blade speculum and scleral marker
B384VS05101 - I² Kit for intraocular injection2019-11-08 Intraocular injection kit - standard set (speculum, marker, 18ga needle, 27ga needle, 30ga needle, gloves, swabs, 1.0 ml syringe
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