ACC00042

GUDID 09342395002285

ELLEX MEDICAL PTY LTD

Ophthalmic ultrasound imaging system
Primary Device ID09342395002285
NIH Device Record Keyea68a229-4826-43de-a8d7-57b8f5d42634
Commercial Distribution StatusIn Commercial Distribution
Brand NameACC00042
Version Model Number40MHz Probe International Accessory Kit
Company DUNS756138509
Company NameELLEX MEDICAL PTY LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS109342395002285 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYOSystem, Imaging, Pulsed Echo, Ultrasonic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-12-04
Device Publish Date2024-11-26

Devices Manufactured by ELLEX MEDICAL PTY LTD

09342395002278 - 40MHZKIT-USA2024-12-04
09342395002285 - ACC000422024-12-04
09342395002285 - ACC000422024-12-04
09342395001370 - Eye Cubed V4 New Gen2024-10-18
09342395000038 - UltraQ2024-10-17
09342395000069 - Solo2024-10-17
09342395000113 - Tango2024-10-17
09342395000137 - UltraQ2024-10-17
09342395000212 - 2RT2024-10-17

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