FDA.reportPublic FDA data

Table for Slit lamp 115V

Primary DI
04049584029751
Brand
Table for Slit lamp 115V
Company
OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung
Model
37481
Device description
Table for Slit lamp 115V
Published
2022-12-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HRJTable, Instrument, Powered, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRJTable, Instrument, Powered, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04049584029751PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049584029751040495840297514049584029751

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic instrument table, line-poweredA mains electricity (AC-powered) device designed as a work surface, with or without storage compartments, that supports ophthalmic instruments (e.g., slit lamp, keratometer, refractometer, and hand instruments) for the examination/treatment of a patient's eyes. It has powered height adjustments enabling the clinician to raise/lower the surface, or seated patient, to align the instruments to the patient's eye level. Some designs may incorporate the patient chair as part of the unit and even facilitate easy swinging aside mechanisms to accommodate wheelchair bound patients. Controls may enable the adjustment of peripheral devices within the examination room.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
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
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
04049584037152BIOM 6100348202026-01-14
04049584037251Twinfield 3100348192026-01-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05904815700467Electric table HE Spectralis BR 110-230VCX ENGINEERING SP Z O OHRJ2026-04-01
00628308210435S4OptikINNOVA Medical Ophthalmics IncHRJ2026-03-31
00628308210459S4OptikINNOVA Medical Ophthalmics IncHRJ2026-03-31
04260647940022Sliding keyboard shelfAKRUS GmbH & Co. KGHRJ2025-11-28
04260647940039Footrest extensionAKRUS GmbH & Co. KGHRJ2025-11-28
00628308210336S4 OPTIKINNOVA Medical Ophthalmics IncHRJ2025-08-21
00628308210343S4 OPTIKINNOVA Medical Ophthalmics IncHRJ2025-08-21
00628308210350S4 OPTIKINNOVA Medical Ophthalmics IncHRJ2025-08-21
00628308210367S4 OPTIKINNOVA Medical Ophthalmics IncHRJ2025-08-21
00850003069616AIT-250WTOPCON HEALTHCARE INCHRJ2025-07-17
05907642694169Ophthalmic Electric TableMDT SP Z O OHRJ2025-07-16
05907642694176Ophthalmic Electric TableMDT SP Z O OHRJ2025-07-16
05907642694183Ophthalmic Electric TableMDT SP Z O OHRJ2025-07-16
05907642694190Ophthalmic Electric TableMDT SP Z O OHRJ2025-07-16
05907642694206Ophthalmic Electric TableMDT SP Z O OHRJ2025-07-16
05907642694213Ophthalmic Electric TableMDT SP Z O OHRJ2025-07-16
05907642694220Ophthalmic Electric TableMDT SP Z O OHRJ2025-07-16
05907642694237Ophthalmic Electric TableMDT SP Z O OHRJ2025-07-16
05907642694268Ophthalmic Electric TableMDT SP Z O OHRJ2025-07-16
05907642694275Ophthalmic Electric TableMDT SP Z O OHRJ2025-07-16
05907642694282Ophthalmic Electric TableMDT SP Z O OHRJ2025-07-16
05907642694299Ophthalmic Electric TableMDT SP Z O OHRJ2025-07-16
05907642694305Ophthalmic Electric TableMDT SP Z O OHRJ2025-07-16
05907642694312Ophthalmic Electric TableMDT SP Z O OHRJ2025-07-16
05907642694329Ophthalmic Electric TableMDT SP Z O OHRJ2025-07-16
05907642694336Ophthalmic Electric TableMDT SP Z O OHRJ2025-07-16
05907642694343Ophthalmic Electric TableMDT SP Z O OHRJ2025-07-16
05907642694350Ophthalmic Electric TableMDT SP Z O OHRJ2025-07-16
00628308210305S4 OptikINNOVA Medical Ophthalmics IncHRJ2025-06-04
00628308210312S4 OptikINNOVA Medical Ophthalmics IncHRJ2025-06-04