FDA.reportPublic FDA data

GALILEI

Primary DI
07640167751242
Brand
GALILEI
Company
SIS AG, Surgical Instrument Systems
Model
G6
Catalog number
410.030.007
Device description
Galilei G6 Lens Professional
Published
2019-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MXKDevice, Analysis, Anterior Segment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MXKDevice, Analysis, Anterior SegmentOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182659000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182659000Galilei G6 Lens ProfessionalSis Ag, Surgical Instrument Systems2019-07-25MXK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640167751242PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640167751242076401677512427640167751242

GMDN Terms#

Term, Definition table
TermDefinition
Optical low coherence reflectometry (OLCR) biometerA mains electricity (AC-powered) ophthalmic device (a biometer) designed to determine the axial dimensions and frontal section of the eye including other biometric parameters/evaluations such as keratometry, white-to-white distance, pupillometry and consequently corneal power based on optical low coherence reflectometry (OLCR), non contact, measurement methods using light markers and digital image processing. It is normally adjustable on a cross stage with an integral chin rest and used to obtain measurements directly from the eye for processing and display via software, e.g., in an attached computer. Patient intraocular lens (IOL) suitability may also be calculated using different formulae.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure690 millibar1060 millibar
Storage Environment Humidity10 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8667084490usa@ziemergroup.com

Regulatory Flags#

DUNS number
480508261
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640167751235GALILEIG4410.030.0042016-09-15
07640167751198AMADEUSTubing130.700.0202016-09-15
07640167751211AMADEUSSurePass130.700.0012016-09-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860003630624BOSSIntelon Optics, Inc.MXK2026-05-22
04049584034953Pentacam Cornea OCTOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungMXK2026-03-31
04571130283343AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIATOPCON CORPORATIONMXK2025-11-17
00380659984372WaveLightAlcon Laboratories, Inc.MXK2025-03-12
03664188000558ESSILORLUNEAU TECHNOLOGY OPERATIONSMXK2025-01-02
03664188000565ESSILORLUNEAU TECHNOLOGY OPERATIONSMXK2025-01-02
08034028770517ESSILORVISIA IMAGING SRLMXK2024-11-04
08034028770487MYAHVISIA IMAGING SRLMXK2023-10-12
03664188000060VisionixLUNEAU TECHNOLOGY OPERATIONSMXK2023-06-08
03664188000404RODENSTOCKLUNEAU TECHNOLOGY OPERATIONSMXK2023-06-08
03664188000923RODENSTOCKLUNEAU TECHNOLOGY OPERATIONSMXK2023-06-08
03664188000930RODENSTOCKLUNEAU TECHNOLOGY OPERATIONSMXK2023-06-08
04059237000730HRT3Heidelberg Engineering GmbHMXK2023-03-03
08034028770463MYOPIA EXPERT 700VISIA IMAGING SRLMXK2022-06-22
08034028770456MYAHVISIA IMAGING SRLMXK2022-06-14
04049584025357Pentacam AXL WaveOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungMXK2021-11-03
04049584029942Myopia MasterOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungMXK2021-11-03
04049584029959Myopia MasterOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungMXK2021-11-03
04059237000747TOMOCAPHeidelberg Engineering GmbHMXK2020-10-29
03664188000039VISIONIXLUNEAU TECHNOLOGY OPERATIONSMXK2020-05-25
03664188000046VISIONIXLUNEAU TECHNOLOGY OPERATIONSMXK2020-05-25
03664188000909VISIONIXLUNEAU TECHNOLOGY OPERATIONSMXK2020-05-25
04573344510024OPTICAL BIOMETERSANTEC CORPORATIONMXK2019-05-22
04059237000334HRT3 Heidelberg Engineering GmbHMXK2017-07-14
04573344510017OPTICAL BIOMETER SANTEC CORPORATIONMXK2017-05-01
04059237000242SPECTRALIS, HRT3, HEPHeidelberg Engineering GmbHMXK2016-12-16
04059237000266HRT3Heidelberg Engineering GmbHMXK2016-09-24
04059237000273HRT3 Heidelberg Engineering GmbHMXK2016-09-24
03664188002200VISIONIXLUNEAU TECHNOLOGY OPERATIONSMXK2016-09-23
03664188001203VISIONIXLUNEAU TECHNOLOGY OPERATIONSMXK2016-09-23