FDA.reportPublic FDA data

Alcon, Engauge

Primary DI
00380657515936
Brand
Alcon, Engauge
Company
Alcon Laboratories, Inc.
Model
8065751593
Device description
25 GA Illuminated Flexible Curved Laser Probe
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HQBPhotocoagulator and accessories
HQEInstrument, vitreous aspiration and cutting, ac-powered
HQFLaser, ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQBPhotocoagulator And AccessoriesOphthalmic2
HQEInstrument, Vitreous Aspiration And Cutting, Ac-PoweredOphthalmic2
HQFLaser, OphthalmicOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10380657515933PackageGS16In Commercial Distribution
00380657515936PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1038065751593310380657515933
00380657515936003806575159363806575159360380657515936

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic laser system beam guideA sterile, hand-held, probe-like device intended to be used in conjunction with an ophthalmic laser system during ophthalmic surgery to invasively direct and deliver laser energy to treat non-refractive conditions (e.g., to repair a retinal tear). It consists of a fibreoptic cable, a handpiece, and a distal invasive cannula/probe which may be available in a variety of configurations (e.g., bent or straight); it may be capable of further functionality (e.g., aspiration, illumination). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Contacts#

Phone, Email table
PhoneEmail
+1(800)862-5266web.masterus@alcon.com

Regulatory Flags#

DUNS number
008018525
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00380658454418Clareon VivityCNWET4CNWET4-0602026-09-04
00380658454425Clareon VivityCNWET4CNWET4-0652026-09-04
00380658454432Clareon VivityCNWET4CNWET4-0702026-09-04
00380658454449Clareon VivityCNWET4CNWET4-0752026-09-04
00380658454456Clareon VivityCNWET4CNWET4-0802026-09-04
00380658454463Clareon VivityCNWET4CNWET4-0852026-09-04
00380658454470Clareon VivityCNWET4CNWET4-0902026-09-04
00380658454487Clareon VivityCNWET4CNWET4-0952026-09-04
00380658454494Clareon VivityCNWET4CNWET4-1002026-09-04
00380658454500Clareon VivityCNWET4CNWET4-1052026-09-04
00380658454517Clareon VivityCNWET4CNWET4-1102026-09-04
00380658454524Clareon VivityCNWET4CNWET4-1152026-09-04
00380658454531Clareon VivityCNWET4CNWET4-1202026-09-04
00380658454548Clareon VivityCNWET4CNWET4-1252026-09-04
00380658454555Clareon VivityCNWET4CNWET4-1302026-09-04
00380658454562Clareon VivityCNWET4CNWET4-1352026-09-04
00380658454579Clareon VivityCNWET4CNWET4-1402026-09-04
00380658454586Clareon VivityCNWET4CNWET4-1452026-09-04
00380658454593Clareon VivityCNWET4CNWET4-1502026-09-04
00380658454609Clareon VivityCNWET4CNWET4-1552026-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00812480011137Bi-Blade®MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.HQE2026-09-27
00812480011151Bi-Blade®MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.HQE2026-09-27
00812480011168Bi-Blade®MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.HQE2026-09-27
00812480011175Bi-Blade®MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.HQE2026-09-27
00812480011182Bi-Blade®MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.HQE2026-09-27
00812480013049NAMEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.HQE2026-09-27
00812480011083Bi-Blade®MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.HQE2026-09-26
00812480011090Bi-Blade®MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.HQE2026-09-26
00812480011144Bi-Blade®MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.HQE2026-09-26
00840096215304XLEND23MULTIFLEXKATALYST SURGICAL LLCHQB2025-06-24
00840096215304XLEND23MULTIFLEXKATALYST SURGICAL LLCHQF2025-06-24
10840096211075Illuminated Laser Probe, OS4, StraightKATALYST SURGICAL LLCHQF2023-06-07
1081748902357720ga Straight Illuminated Laser Probe, 19ga Needle Illumination, AlconKATALYST SURGICAL LLCHQF2020-11-27
1081748902358420ga Straight Illuminated Laser Probe, 19ga Needle Illumination, QuantelKATALYST SURGICAL LLCHQF2020-11-27
1081748902359120ga Straight Illuminated Laser Probe, 19ga Needle Illumination, NidekKATALYST SURGICAL LLCHQF2020-11-27
1081748902356020ga Straight Illuminated Laser Probe, 19ga Needle Illumination, IridexKATALYST SURGICAL LLCHQF2020-11-25
1084009621334527ga Stiff MultiFlex Inverted Extendable Laser Probe, Iridex ConnectorKATALYST SURGICAL LLCHQF2020-10-27
1084009621335227ga Stiff MultiFlex Inverted Extendable Laser Probe, Alcon ConnectorKATALYST SURGICAL LLCHQF2020-10-27
1084009621336927ga Stiff MultiFlex Inverted Extendable Laser Probe, Quantel ConnectorKATALYST SURGICAL LLCHQF2020-10-27
1084009621337627ga Stiff MultiFlex Inverted Extendable Laser Probe, Nidek ConnectorKATALYST SURGICAL LLCHQF2020-10-27
1084009621338327ga Stiff MultiFlex Inverted Extendable Laser Probe, Dorc ConnectorKATALYST SURGICAL LLCHQF2020-10-27
1084009621123520ga Straight Laser ProbeKATALYST SURGICAL LLCHQF2020-03-04
1084009621124223ga Straight Laser ProbeKATALYST SURGICAL LLCHQF2020-03-04
1084009621125925ga Straight Laser ProbeKATALYST SURGICAL LLCHQF2020-03-04
1084009621126627ga Straight Laser ProbeKATALYST SURGICAL LLCHQF2020-03-04
1084009621127323ga Flexible Curved Laser ProbeKATALYST SURGICAL LLCHQF2020-03-04
1084009621128025ga Flexible Curved Laser ProbeKATALYST SURGICAL LLCHQF2020-03-04
1084009621129727ga Flexible Curved Laser ProbeKATALYST SURGICAL LLCHQF2020-03-04
1084009621130320ga Illuminated Straight Laser ProbeKATALYST SURGICAL LLCHQF2020-03-04
1084009621131023ga Illuminated Straight Laser ProbeKATALYST SURGICAL LLCHQF2020-03-04