FDA.reportPublic FDA data

HRT3

Primary DI
04059237000334
Brand
HRT3
Company
Heidelberg Engineering GmbH
Model
Rostock Cornea Module SW V1.5a
Published
2017-07-14
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
MXKDevice,Analysis,Anterior Segment

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04059237000334PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04059237000334040592370003344059237000334

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic slit lamp, examinationA mains electricity (AC-powered), ophthalmic, binocular microscope designed to examine the interior anatomy of the eye (anterior and posterior surfaces) by viewing through the iris. It produces a narrow slit of powerful light which is projected into the eye, and resulting light reflections are detected obliquely with a travelling microscope to enable observation of the internal ocular surfaces. It is used to perform a variety of measurements [e.g., intraocular pressure (IOP) or tonometry, corneal thickness, anterior chamber depth] and to evaluate symptoms (e.g., eye itchiness, grittiness, pain, dry eyes, photophobia, and reduced visual acuity).

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
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
04059237000068SPECTRALISSP-PWS-2001A2016-09-24

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
07640167751242GALILEISIS AG, Surgical Instrument SystemsMXK2019-09-20
04573344510024OPTICAL BIOMETERSANTEC CORPORATIONMXK2019-05-22
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