FDA.reportPublic FDA data

Patient Interface 125 Kit

Primary DI
04050555000990
Brand
Patient Interface 125 Kit
Company
Technolas Perfect Vision GmbH
Model
1
Catalog number
90000115
Device description
Patient Interface Kit for VICTUS™ Femtosecond Laser Platform (software version 2.7 and higher).Kit consists of Patient Interface 125 and Suction Clip 125.
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HQFLaser, Ophthalmic
OOEOphthalmic Femtosecond Laser

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQFLaser, OphthalmicOphthalmic2
OOEOphthalmic Femtosecond LaserOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04050555000990PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04050555000990040505550009904050555000990

GMDN Terms#

Term, Definition table
TermDefinition
Laser beam delivery unit holderA device designed to be used together with a laser delivery unit to provide support to the delivery unit during the operation of the laser. The holder will help with the positioning of the final laser beam output and increase safety from inadvertent movement which would be undesirable. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature5 Degrees Celsius35 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4989940040info@technolaspv.com

Regulatory Flags#

DUNS number
341325716
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04050555002086Patient Interface 125 Kit900001452024-03-13
04050555004165VICTUS VERAFIT Patient Interface Kit190000200TPV2016-12-05
04050555004202TECHNOLAS TENEO 317Model22023-12-17
04050555000839MICROKERATOME Disposable Tubing150700632016-09-24
04050555000976ACCUGLIDE® Disposable Blade150700602016-09-19
04050555000983Zyoptix® XP Microkeratome Disposable Blades150700702016-09-24
04050555002895VICTUS™ Femtosecond Laser Platform3.2140002016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10840096211075Illuminated Laser Probe, OS4, StraightKATALYST SURGICAL LLCHQF2023-06-07
08717872014142Directional Laser Probe with Alcon / Lumenis connector.(20 gauge / 0.9 mm)D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2022-07-01
08717872014173Directional Laser Probe with Alcon / Lumenis connector.(23 gauge / 0.6 mm)D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2022-07-01
08717872014203Directional Laser Probe with Alcon / Lumenis connector.(25 gauge / 0.5 mm)D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2022-07-01
08717872014968Directional Laser Probe with DORC connector.(25 gauge / 0.5 mm)D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2022-07-01
08717872014975Directional Laser Probe with DORC connector.(20 gauge / 0.9 mm)D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2022-07-01
08717872014982Directional Laser Probe with DORC connector.(23 gauge / 0.6 mm)D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2022-07-01
1081748902371320ga Curved Illuminated Laser Probe, 19ga Needle Illumination, IridexKATALYST SURGICAL LLCHQF2020-11-28
1081748902372020ga Curved Illuminated Laser Probe, 19ga Needle Illumination, AlconKATALYST SURGICAL LLCHQF2020-11-28
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1081748902376823ga Flexible Tapered Illuminated Laser Probe, Iridex CompatibleKATALYST SURGICAL LLCHQF2020-11-28
1081748902377523ga Flexible Tapered Illuminated Laser Probe, Alcon CompatibleKATALYST SURGICAL LLCHQF2020-11-28
1081748902378223ga Flexible Tapered Illuminated Laser Probe, Quantel CompatibleKATALYST SURGICAL LLCHQF2020-11-28
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1081748902380523ga Flexible Tapered Illuminated Laser Probe, DORC CompatibleKATALYST SURGICAL LLCHQF2020-11-28
1081748902381225ga Flexible Tapered Illuminated Laser Probe, Iridex CompatibleKATALYST SURGICAL LLCHQF2020-11-28
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1081748902384325ga Flexible Tapered Illuminated Laser Probe, Nidek CompatibleKATALYST SURGICAL LLCHQF2020-11-28
1081748902385025ga Flexible Tapered Illuminated Laser Probe, DORC CompatibleKATALYST SURGICAL LLCHQF2020-11-28
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
1081748902360720ga Straight Illuminated Laser Probe, 19ga Needle Illumination, DORCKATALYST SURGICAL LLCHQF2020-11-27
1081748902362123ga Straight Illuminated Laser Probe, 19ga Needle Illumination, AlconKATALYST SURGICAL LLCHQF2020-11-27
1081748902363823ga Straight Illuminated Laser Probe, 19ga Needle Illumination, QuantelKATALYST SURGICAL LLCHQF2020-11-27
1081748902364523ga Straight Illuminated Laser Probe, 19ga Needle Illumination, NidekKATALYST SURGICAL LLCHQF2020-11-27
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