FDA.reportPublic FDA data

Ellex

Primary DI
09342395002032
Brand
Ellex
Company
ELLEX MEDICAL PTY LTD
Model
3139150
Device description
FASSY SYSTEM,SDS, ZEISS SL130, LP4532
Published
2016-09-26
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
HQFLaser, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQFLaser, OphthalmicOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09342395002032PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09342395002032093423950020329342395002032

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic slit lamp, examinationAn electrically-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

Contacts#

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

Regulatory Flags#

DUNS number
756138509
Device count
1
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
09342395000540EllexCOLUMN_HV2023-06-09
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10757770060464Bausch + LombBausch & Lomb IncorporatedHQF2026-04-09
10757770060471Bausch + LombBausch & Lomb IncorporatedHQF2026-04-09
10757770060488Bausch + LombBausch & Lomb IncorporatedHQF2026-04-09
08717872036526EVA Cartridge with 0.5 L Collection BagD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2025-03-31
08717872036489EVA NEXUS™ Irrigation and Aux. Aspiration TubingD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2025-03-31
08717872036496EVA NEXUS™ Infusion Giving SetD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2025-03-31
08717872036502EVA Nexus™ Irrigation TubingD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2025-03-31
08717872036618EVA Nexus™ Aux. Aspiration TubingD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2025-03-31
08717872036625EVA NEXUS™ cartridge with 0,5 L collection bagD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2025-03-31
08717872034713CUSTOM TDC VITREC.PACK VGP 25GD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2024-09-27
08717872034652EVA Vitrectomy Pack VGPC Input 20GD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2024-02-20
08717872034683EVA TDC Vitrectomy Pack VGPC Input 23GD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2024-02-20
08717872034690EVA TDC Vitrectomy Pack VGPC Input 25GD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2024-02-20
08717872034706EVA TDC Vitrectomy Pack VGPC Input 27GD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2024-02-20
08717872032672EVA Custom TDC Vitrectomy Pack VGPC Input 25GD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2024-02-15
08717872032702EVA Custom TDC Vitrectomy Pack VGPC Input 27GD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2024-02-15
08717872032122EVA Vitrectomy Pack Gravity Input 23GD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2022-12-08
08717872032139EVA Vitrectomy Pack VGPC Input 23GD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2022-12-08
08717872032146EVA Vitrectomy Pack Gravity Input 25GD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2022-12-08
08717872032153EVA Vitrectomy Pack VGPC Input 25GD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2022-12-08
08717872032160EVA TDC Vitrectomy Pack Gravity Input 23GD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2022-12-08
08717872032177EVA TDC Vitrectomy Pack VGPC Input 23GD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2022-12-08
08717872032184EVA TDC Vitrectomy Pack Gravity Input 25GD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2022-12-08
08717872032191EVA TDC Vitrectomy Pack VGPC Input 25GD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2022-12-08
08717872032221EVA TDC Vitrectomy Pack Gravity Input 27GD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2022-12-08
08717872032238EVA TDC Vitrectomy Pack VGPC Input 27GD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2022-12-08
08717872034430EVA NEXUS™, Phaco vitrectomy system including laser with DORC connectorD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2022-08-01
08717872034447EVA NEXUS™, Phaco vitrectomy system including laser with SMA connectorD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2022-08-01
08717872014142Directional Laser Probe with Alcon / Lumenis connector.(20 gauge / 0.9 mm)D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2022-07-01
08717872014173Directional Laser Probe with Alcon / Lumenis connector.(23 gauge / 0.6 mm)D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2022-07-01