Ellex

Basic Information

• Brand Name: Ellex
• Primary DI: 09342395000526
• Version / Model: TS_MOBILE
• Company Name: ELLEX MEDICAL PTY LTD
• Labeler DUNS: 756138509
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-09
• Public Version: 2
• Public Version Date: 2023-10-04
• Public Version Status: Update
• Public Device Record Key: 595a01ac-8bdb-4e03-ac99-d23ce62cc5e2

Device Description

FGOODS, MOBILE, STAND

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HRJ	Table, Instrument, Powered, Ophthalmic	Ophthalmic	886.4855	1

GMDN Terms

Code	Name	Definition	Implantable	Status
65697	Transportable medical equipment stand, electrically-powered	An electrically-powered transportable device [e.g., on wheels or easily movable] 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	09342395000526	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]