Ellex

Basic Information

• Brand Name: Ellex
• Primary DI: 09342395000588
• Version / Model: 6328990
• Company Name: ELLEX MEDICAL PTY LTD
• Labeler DUNS: 756138509
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 7
• Public Version Date: 2021-11-22
• Public Version Status: Update
• Public Device Record Key: a448e94b-c8a2-443e-8f6d-8b5596fcbaa0

Device Description

ACC. SPECTACLES, SAFETY, 523nm & 1064nm (TANGO)

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: No
• 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
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	878.4810	2
HQF	Laser, Ophthalmic	Ophthalmic	886.4390	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36309	Laser beam eye protector, patient	A protective device that is designed to be placed either under or over the patient's eyelids in order to protect the eyes from injury during laser surgery.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	09342395000588	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K021550	000
K041598	000
K122202	000
K992824	000