20ga Flexible Tapered Laser Probe - Alcon Compatib VS0130.20A

GUDID B384VS013020A5

20ga Flexible Tapered Laser Probe - Alcon 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 IDB384VS013020A5
NIH Device Record Key104d3252-38e3-4c83-9522-a4585101d863
Commercial Distribution StatusIn Commercial Distribution
Brand Name20ga Flexible Tapered Laser Probe - Alcon Compatib
Version Model NumberVS0130.20A
Catalog NumberVS0130.20A
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 Gauge20 Gauge
Needle Gauge20 Gauge
Needle Gauge20 Gauge
Needle Gauge20 Gauge
Needle Gauge20 Gauge
Needle Gauge20 Gauge
Needle Gauge20 Gauge
Needle Gauge20 Gauge
Needle Gauge20 Gauge
Needle Gauge20 Gauge
Needle Gauge20 Gauge
Needle Gauge20 Gauge
Needle Gauge20 Gauge
Needle Gauge20 Gauge
Needle Gauge20 Gauge
Needle Gauge20 Gauge
Needle Gauge20 Gauge

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB384VS013020A1 [Primary]
HIBCCB384VS013020A5 [Package]
Contains: B384VS013020A1
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

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