LenSx, Alcon

GUDID 10380659982252

LENSX LASER SOFTFIT PATIENT

Alcon Laboratories, Inc.

Ophthalmic surgical procedure kit, non-medicated, single-use Ophthalmic surgical procedure kit, non-medicated, single-use Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup
Primary Device ID10380659982252
NIH Device Record Keyf857f6df-c3e8-4d16-90b3-274a4aefbb89
Commercial Distribution StatusIn Commercial Distribution
Brand NameLenSx, Alcon
Version Model Number8065998225
Company DUNS008018525
Company NameAlcon Laboratories, Inc.
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)862-5266
Emailweb.masterus@alcon.com
Phone+1(800)862-5266
Emailweb.masterus@alcon.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100380659982255 [Primary]
GS110380659982252 [Package]
Contains: 00380659982255
Package: Box [10 Units]
In Commercial Distribution
GS120380659982259 [Package]
Package: [4 Units]
In Commercial Distribution

FDA Product Code

HQCUnit, phacofragmentation

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-11-08
Device Publish Date2016-09-24

Devices Manufactured by Alcon Laboratories, Inc.

00047113604978 - Clear Care2024-03-27 Clear Care Cleaning & Disinfecting Solution Twin Pack 2 x 16 oz. plus 3 oz. Travel Size
00047113609027 - Clear Care2024-03-27 Clear Care Cleaning & Disinfecting Solution Twin Pack 2 x 12 oz.
00047113609034 - Clear Care2024-03-27 Clear Care Cleaning & Disinfecting Solution 3 oz. Travel Kit
00047113609126 - Clear Care2024-03-27 Clear Care Cleaning & Disinfecting Solution 12 oz.
00380657530571 - Centurion2023-05-02 Centurion Vision System With Active Sentry
10380650000535 - LENSX2022-11-14 LENSX LASER SOFTFIT PATIENT INTERFACE 10 PK, EO
20380650000549 - LENSX2022-11-14 LENSX SOFTFIT PATIENT INTERFACE NOMINAL,EO
20380650000556 - LENSX2022-11-14 LENSX SOFTFIT PATIENT INTERFACE STEEP,EO

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