FDA.reportPublic FDA data

Easyfield S

Primary DI
04049584000064
Brand
Easyfield S
Company
OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung
Model
15005
Device description
The OCULUS Easyfield® has been designed for combined use as ascreening unit with all associated options for immediate follow-upexamination of suspicious findings. The most common examination gridsand strategies for the central visual field up to 30° can be accessed.The Easyfield® offers pre programmed combinations for often neededexamination routines. For example: Screening 24-2, SPARK Quick,Macula. You can also combine your own routines and then save them asa program.
Published
2016-09-01
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
HOOPerimeter, Ac-Powered

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04049584000064PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049584000064040495840000644049584000064

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth450Millimeter
Height435Millimeter
Weight4.6Kilogram
Width275Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius55 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
317138956
Device count
1
Premarket exempt
true
Serial number
true
Donation ID number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04049584037794WE CARE Multi-Purpose-Solution, 100 ml100483932026-07-30
04049584037800WE CARE Multi-Purpose-Solution, 360 ml100483942026-07-30
04049584034953Pentacam Cornea OCT100190012026-03-31
04049584037909Cable SDI BIOM 6 for Alcon LuxOR Revalia100401382026-02-11
04049584037916Cable Y BIOM 6 for Haag Streit Metis 900100401372026-02-11
04049584037930Cable CAN BIOM 6 for Leica Proveo 8 / 8x100413192026-02-11
04049584037954Cable CTRL BIOM 6 for Leica Proveo 8 / 8x100432282026-02-11
04049584037961Cable Y BIOM 6 for Alcon LuxORRevalia100425572026-02-11
04049584038012Cable CAN BIOM 6 for B&L SeeLuma100428332026-02-11
04049584037695Focusing Module BIOM 6, 175 mm100351102026-01-23
04049584037701Focusing Module BIOM 6, 200 mm100379072026-01-23
04049584037718Precision Mount for B&L100394002026-01-23
04049584037725Precision Mount for Leica100390582026-01-23
04049584037732Precision Mount for Alcon100291772026-01-23
04049584037749Precision Mount for Zeiss100392342026-01-23
04049584037756Precision Mount for Haag Streit100291782026-01-23
04049584035714BIOM 6 HD Optic Set for f=175 mm100299002026-01-14
04049584035721BIOM 6 HD Optic Set for f=200 mm100299022026-01-14
04049584035738BIOM 6 HD Optic Set for f=175 mm100299002026-01-14
04049584035745BIOM 6 HD Optic Set for f=200 mm100299022026-01-14

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
04059237000372HEPHeidelberg Engineering GmbHHOO2018-07-11
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