Trabectome I/A Console (100-240V)

Basic Information

• Brand Name: Trabectome I/A Console (100-240V)
• Primary DI: 10854028002167
• Version / Model: 550014-02
• Catalog Number: 550014-02
• Company Name: NEOMEDIX CORPORATION
• Labeler DUNS: 945496792
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-28
• Public Version: 4
• Public Version Date: 2019-12-16
• Public Version Status: Update
• Public Device Record Key: db350c71-aad4-46ce-a4d3-a3b7f7c124e7

Device Description

The Trabectome I/A Console (100-240V) is an aspiration pump for use in general surgery applications where aspiration of irrigation and waste fluids from a surgical site is desired,

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: No
• 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
BTA	Pump, Portable, Aspiration (Manual Or Powered)	General, Plastic Surgery	878.4780	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36586	Ophthalmic irrigation/aspiration pump	A mains electricity (AC-powered), ophthalmic device used to irrigate the area pertaining to the eye and eye cavity with a fluid to provide a flushing effect during ophthalmic surgery and also to aspirate by drawing liquid out of the pertinent area. It will be used for the removal of, e.g., debris, tissue or fluids from the site, and will assist the operator by keeping the site cleared and improving the field of observation. It is commonly used during cataract operations and can generate a positive and/or negative pressure with its pumping systems and is used together with compatible instruments. This device must operate at extremely low pressure to avoid inadvertent damage to the site.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10854028002167	GS1

Customer Contacts

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