23ga Flexible Tapered Laser Probe - Alcon Compatib VS0130.23A

GUDID B384VS013023A5

23ga Flexible Tapered Laser Probe - Alcon Compatible

VORTEX SURGICAL, LLC

Ophthalmic laser system beam guide
Primary Device IDB384VS013023A5
NIH Device Record Key6d9c7143-5843-439b-8f28-b5d32026ac0a
Commercial Distribution StatusIn Commercial Distribution
Brand Name23ga Flexible Tapered Laser Probe - Alcon Compatib
Version Model NumberVS0130.23A
Catalog NumberVS0130.23A
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 Gauge23 Gauge
Needle Gauge23 Gauge
Needle Gauge23 Gauge
Needle Gauge23 Gauge
Needle Gauge23 Gauge
Needle Gauge23 Gauge
Needle Gauge23 Gauge
Needle Gauge23 Gauge
Needle Gauge23 Gauge
Needle Gauge23 Gauge
Needle Gauge23 Gauge
Needle Gauge23 Gauge
Needle Gauge23 Gauge
Needle Gauge23 Gauge
Needle Gauge23 Gauge
Needle Gauge23 Gauge
Needle Gauge23 Gauge

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB384VS013023A1 [Primary]
HIBCCB384VS013023A5 [Package]
Contains: B384VS013023A1
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

VS01102319 - 23ga Straight Laser Probe2020-02-06 23ga Straight Laser Probe
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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.