25ga Straight Laser Probe - Alcon Compatible VS0110.25A

GUDID B384VS011025A5

25ga Straight Laser Probe - Alcon Compatible

VORTEX SURGICAL, LLC

Ophthalmic laser system beam guide
Primary Device IDB384VS011025A5
NIH Device Record Key7e228155-73e6-4d3b-a593-0a7e03cb3409
Commercial Distribution StatusIn Commercial Distribution
Brand Name25ga Straight Laser Probe - Alcon Compatible
Version Model NumberVS0110.25A
Catalog NumberVS0110.25A
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 Gauge25 Gauge
Needle Gauge25 Gauge
Needle Gauge25 Gauge
Needle Gauge25 Gauge
Needle Gauge25 Gauge
Needle Gauge25 Gauge
Needle Gauge25 Gauge
Needle Gauge25 Gauge
Needle Gauge25 Gauge
Needle Gauge25 Gauge
Needle Gauge25 Gauge
Needle Gauge25 Gauge
Needle Gauge25 Gauge
Needle Gauge25 Gauge
Needle Gauge25 Gauge
Needle Gauge25 Gauge
Needle Gauge25 Gauge

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB384VS011025A1 [Primary]
HIBCCB384VS011025A5 [Package]
Contains: B384VS011025A1
Package: box [10 Units]
In Commercial Distribution

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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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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