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SPECTRALIS, HRT3, HEP

Primary DI
04059237000242
Brand
SPECTRALIS, HRT3, HEP
Company
Heidelberg Engineering GmbH
Model
HEYEX 2 SW V2.2
Published
2016-12-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HPTPerimeter, Automatic, Ac-Powered
MXKDevice,Analysis,Anterior Segment
MYCOphthalmoscope,Laser,Scanning
OBOTomography, Optical Coherence

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HPTPerimeter, Automatic, Ac-PoweredOphthalmic1
MXKDevice, Analysis, Anterior SegmentOphthalmic2
MYCOphthalmoscope, Laser, ScanningOphthalmic2
OBOTomography, Optical CoherenceOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04059237000242PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04059237000242040592370002424059237000242

GMDN Terms#

Term, Definition table
TermDefinition
Spectral-domain optical coherence tomography systemA mobile assembly of devices designed to use near infrared (NIR) LED light aimed into the eye to acquire, process, display and save in vivo depth-resolved images of anterior and posterior ocular tissue microstructures in clinical and perioperative examination through the use of interchangeable lenses. Spectral domain optical coherence tomography (SDOCT) is intended to aid in the diagnosis and evaluation of physiologic and pathologic conditions of the eye through non-contact optical imaging. Reflected light is picked up by a detector that converts it into electrical signals using a computer and dedicated software, providing cross-sectional or three-dimensional (3-D) volume scans for analysis.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
329833875
Device count
1
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04059237000976SPECTRALISSoftware V7.4-US2026-07-07
04059237000235SPECTRALIS86549865492025-03-24
04059237000723SPECTRALISS3610 [SN>20000]2024-10-04
04059237000792SPECTRALISS2610 [SN>20000] 2024-10-04
04059237001027SPECTRALIS Software V.7.2-US 2024-10-04
04059237001034SPECTRALISSoftware V.7.2-US with Heidelberg Eye Explorer2024-10-04
04059237000884SPECTRALISS10022022-10-26
04059237000891SPECTRALISS20022022-10-26
04059237000815SPECTRALISSoftware V7.0-US2022-02-02
04059237000839SPECTRALISSoftware with HEYEX 2 V7.0-US 2022-02-02
04059237000464SPECTRALISSoftware 6.13_US2020-01-21
04059237000488SPECTRALISSoftware with HEYEX 2 V6.14_US2020-01-21
04059237000716SPECTRALISSP-PWS-2001A [>20000]2019-10-29
04059237000570SPECTRALISSoftware 6.12_US2019-04-23
04059237000594SPECTRALISSoftware with HEYEX 2 V6.12_US2019-04-23
04059237000013SPECTRALISSPEC-CAM-S16002016-09-24
04059237000020SPECTRALISSPEC-CAM-S20002016-09-24
04059237000037SPECTRALISSPEC-CAM-S36002016-09-24
04059237000044SPECTRALISSP-PWS-1000A2016-09-24
04059237000051SPECTRALISSP-PWS-2000A2016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04059237000976SPECTRALISHeidelberg Engineering GmbHOBO2026-07-07
04059237000976SPECTRALISHeidelberg Engineering GmbHMYC2026-07-07
00860001720440CarrotVirtual Field, Inc.HPT2026-06-10
00860001720457CarrotVirtual Field, Inc.HPT2026-06-10
00860001720464CarrotVirtual Field, Inc.HPT2026-06-10
00860003630624BOSSIntelon Optics, Inc.MXK2026-05-22
06975449020015SYLChongQing SS Medical Equipments Co., LtdHPT2026-05-14
06975449020053SYLChongQing SS Medical Equipments Co., LtdHPT2026-05-14
06975449020060S4OPTIKChongQing SS Medical Equipments Co., LtdHPT2026-05-14
08053677040123EIDONCENTERVUE SPAMYC2026-04-29
08053677040130MAIACENTERVUE SPAMYC2026-04-29
04049584034953Pentacam Cornea OCTOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungOBO2026-03-31
04049584034953Pentacam Cornea OCTOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungMXK2026-03-31
04049584037251Twinfield 3OCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHPT2026-01-14
04571130283343AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIATOPCON CORPORATIONMXK2025-11-17
00860011691761Radius InspireRadiusXR, Inc.HPT2025-09-22
045601262691023D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(Type:Maestro2)TOPCON CORPORATIONOBO2025-09-11
G744OCUB100OcuMet BeaconOcuSciences, Inc.MYC2025-06-25
04059237000235SPECTRALISHeidelberg Engineering GmbHOBO2025-03-24
04059237000235SPECTRALISHeidelberg Engineering GmbHMYC2025-03-24
00380659984372WaveLightAlcon Laboratories, Inc.MXK2025-03-12
G617RVF2001RetinaLogikRetinalogik Inc.HPT2025-03-07
04059237000952ANTERIONHeidelberg Engineering GmbHOBO2025-02-05
03664188000558ESSILORLUNEAU TECHNOLOGY OPERATIONSMXK2025-01-02
03664188000565ESSILORLUNEAU TECHNOLOGY OPERATIONSMXK2025-01-02
00860010709719Virtual Eye PROVirtual Vision HealthHPT2024-12-16
00860010709726Virtual Eye ELITE SVirtual Vision HealthHPT2024-12-16
00860010709795Virtual Eye SoftwareVirtual Vision HealthHPT2024-12-16
G617RVF1001RetinaLogikRetinalogik Inc.HPT2024-12-02
00860010709788Virtual Eye SoftwareVirtual Vision HealthHPT2024-11-27