FDA.reportPublic FDA data

Ellex

Primary DI
09342395000540
Brand
Ellex
Company
ELLEX MEDICAL PTY LTD
Model
COLUMN_HV
Published
2023-06-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
09342395000540PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09342395000540093423950005409342395000540

GMDN Terms#

Term, Definition table
TermDefinition
Mobile medical equipment stand, electrically-poweredAn electrically-powered mobile device (on wheels) designed to support medical equipment used for clinical purposes [e.g., in an operating room and/or an examination/treatment room]. It includes an electronic feature (electrical-articulation and/or an integrated battery to provide power for equipment). The equipment to be supported is not included.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
999-999-9999xxx@xx.xx

Regulatory Flags#

DUNS number
756138509
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
09342395000106Integre Pro Red/GreenLP1RG2016-09-24
09342395000588Ellex63289902016-09-24
09342395000502EllexTS_ACCESS2023-06-09
09342395000519EllexTS_ACCESS-MOBILE2023-06-09
09342395000526EllexTS_MOBILE2023-06-09
09342395000557EllexCOLUMN_LV2023-06-09
0934239500227840MHZKIT-USA40MHZ ACCESSORY KIT-USA2024-11-26
09342395002285ACC0004240MHz Probe International Accessory Kit2024-11-26
09342395001370Eye Cubed V4 New GenI3 SYSTEM-ABDU2016-09-24
09342395000038UltraQ ReflexLQP3106-U2016-09-24
09342395000175Solitaire LP45322016-09-23
09342395000199SOLITAIRE LP45322016-09-24
09342395000069SoloLT5106-S2016-09-24
09342395000113TangoLT5106-T2016-09-23
09342395000137UltraQLQP3106-U 2016-09-24
093423950002122RTLR15322016-09-24
09342395000090Integre ProLP55322016-09-24
09342395000120Integre Pro YellowLP5612016-09-24
09342395000144Integre Pro Scan Red-GreenLP6RG2016-03-02
09342395000151Integre Pro Scan Red-YellowLP6RY2016-09-24

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