FDA.reportPublic FDA data

HEP

Primary DI
04059237000372
Brand
HEP
Company
Heidelberg Engineering GmbH
Model
HEP with HEYEX 2 SW V3.2c
Published
2018-07-11
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
HOOPerimeter, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HOOPerimeter, Ac-PoweredOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04059237000372PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04059237000372040592370003724059237000372

GMDN Terms#

Term, Definition table
TermDefinition
Perimeter, automaticA mains electricity (AC-powered), automatically operated, diagnostic, ophthalmic instrument intended for assessing the extent of the patient's peripheral visual field. Small luminous points (spots) are automatically displayed in various random positions and patient response is automatically recorded. The print-out (chart) then shows the resulting curve of the visual field. Such types include Humphrey perimeters.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
329833875
Device count
1
Premarket exempt
true
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
04049584037251Twinfield 3OCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHOO2026-01-14
04560323643804TAKAGITAKAGI SEIKO CO.,LTD.HOO2023-06-09
04049584000040Twinfield 2OCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHOO2022-12-01
04049584000125Centerfield 2OCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHOO2022-12-01
04049584019363SmartfieldOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHOO2022-11-30
04059237000396SPECTRALIS, HEPHeidelberg Engineering GmbHHOO2018-07-11
04057748085215Humphrey FDTCarl Zeiss Meditec, Inc.HOO2018-06-13
04057748085239Humphrey Matrix Carl Zeiss Meditec, Inc.HOO2018-06-13
04049584000057Easyfield COCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHOO2016-09-01
04049584000064Easyfield SOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHOO2016-09-01