25ga Bending Laser Probe - Iridex Compatible VS0140.25I

GUDID B384VS014025I5

25ga Bending Laser Probe - Iridex Compatible

VORTEX SURGICAL, LLC

Ophthalmic laser system beam guide
Primary Device IDB384VS014025I5
NIH Device Record Key6dfd5327-23fb-42cc-a70a-cbd982b3b80c
Commercial Distribution StatusIn Commercial Distribution
Brand Name25ga Bending Laser Probe - Iridex Compatible
Version Model NumberVS0140.25I
Catalog NumberVS0140.25I
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
HIBCCB384VS014025I1 [Primary]
HIBCCB384VS014025I5 [Package]
Contains: B384VS014025I1
Package: Box [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HQBPhotocoagulator And Accessories

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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VS01202316 - 23ga Curved Laser Probe2020-02-06 23ga Curved Laser Probe
VS01202518 - 25ga Curved Laser Probe2020-02-06 25ga Curved Laser Probe
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