MAXX LUXX LED

Basic Information

• Brand Name: MAXX LUXX LED
• Primary DI: 00815871022101
• Version / Model: AHS SD2SD2P3M1-V
• Company Name: Avante
• Labeler DUNS: 178440426
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-28
• Public Version: 5
• Public Version Date: 2020-09-30
• Public Version Status: Update
• Public Device Record Key: 42c7e42a-a018-4d5c-b642-499d95bda55b

Device Description

DUAL MAXX LUXX LED, HD CAM & MONITOR ARM

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: 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
FST	Light, Surgical, Fiberoptic	General, Plastic Surgery	878.4580	2

GMDN Terms

Code	Name	Definition	Implantable	Status
32245	Medical monitor/light mount	A permanently-fixed structure designed to support a light and/or an image display monitor that is used for medical purposes [e.g., in an operating room (OR) and/or an examination/treatment room]. The mount is intended to be permanently-fixed to the ceiling and/or wall. This device will be designed to enable dynamic positioning (e.g., with dynamic arms, sliding bracket); the device to be mounted (medical light/monitor) is not included.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00815871022101	GS1

Premarket Submissions

Submission Number	Supplement Number
K100388	000