Ellex

GUDID 09342395000274

FGOODS, EYEONE

ELLEX MEDICAL PTY LTD

Ophthalmic ultrasound imaging system

• Primary Device ID: 09342395000274
• NIH Device Record Key: de38a9cd-b38b-49b6-a9af-ce352bdb2f24
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ellex
• Version Model Number: EYEONE
• Company DUNS: 756138509
• Company Name: ELLEX MEDICAL PTY LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	09342395000274 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103608

FDA Product Code

• IYO: System, Imaging, Pulsed Echo, Ultrasonic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-19
• Device Publish Date: 2023-06-09

On-Brand Devices [Ellex]

• 09342395000649: ACC. FOOTSWITCH, TANGO/ULTRAQ
• 09342395000588: ACC. SPECTACLES, SAFETY, 523nm & 1064nm (TANGO)
• 09342395001172: ACC.LIO, L2RG
• 09342395001165: ACC.LIO, L2RY
• 09342395000861: ACC.LIO, LP1RG
• 09342395000687: ACCESSORY, LIO, LP4532
• 09342395001141: ACC., TONOMETER POST, HS BQ 900 SLITLAMP
• 09342395000885: ACC. ADAPTER, C/W MICROMANIPULATOR, HS
• 09342395000878: ACC. ADAPTER, FIXED, HAAG STREIT
• 09342395000809: ACC. SAFETY FILTER, FIXED, LEICA 840 (SOLITAIRE)
• 09342395000793: ACC. MSF, ENDOPROBE, GREEN, WILD (SOLITAIRE)
• 09342395000786: ACC. MSF, ENDOPROBE, GREEN, ZEISS (SOLITAIRE)
• 09342395000700: ACC. SAFETY FILTER, WILD/LEICA, FIXED (SOLITAIRE)
• 09342395000694: ACC. SAFETY FILTER, ZEISS/MOELLER, FIXED (SOLITAIRE)
• 09342395000670: ACC. ADAPTER, HAAG STREIT W/ SWINGOUT (SOLITAIRE)
• 09342395000427: ULTRAQ_R_G
• 09342395000267: INTEGRESCAN-GY
• 09342395000243: INTEGRESCAN-G
• 09342395000236: INTEGREPRO-RY
• 09342395000199: SOLITAIRE-SGS
• 09342395000175: SOLITAIRE-DGS
• 09342395000168: INTEGRESCAN-Y
• 09342395000151: INTEGRESCAN-RY
• 09342395000144: INTEGRESCAN-RG
• 09342395000120: INTEGREPRO-Y
• 09342395000106: INTEGREPRO-RG
• 09342395000090: INTEGREPRO-G
• 09342395002032: FASSY SYSTEM,SDS, ZEISS SL130, LP4532
• 09342395002025: FASSY SYSTEM, ZEISS 30SL
• 09342395000892: ACC. 30XL SLITLAMP MICROSCOPE
• 09342395000557: COLUMN_LV
• 09342395000526: FGOODS, MOBILE, STAND
• 09342395000519: FGOODS, WHEELCHAIR ACCESSIBLE, MOBILE
• 09342395000502: FGOODS, WHEELCHAIR ACCESSIBLE, STAND
• 09342395000373: FGOODS, EYE PRIME
• 09342395000274: FGOODS, EYEONE