VISION LED

Basic Information

• Brand Name: VISION LED
• Primary DI: 00815871021685
• Version / Model: DRE 061512-V
• Company Name: Avante
• Labeler DUNS: 178440426
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 8
• Public Version Date: 2023-10-04
• Public Version Status: Update
• Public Device Record Key: 57fd48f5-b3b7-46fe-826e-e8d4d31acfad

Device Description

DRE Vision LED, WALL MOUNT

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
42513	Transportable medical equipment stand, non-powered	A non-powered (non-active) 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 may include manually-adjustable articulated arms to enable dynamic positioning of equipment; the equipment to be supported is not included. The device does not include a battery pack but might include a battery holder and electrical connection wiring to feed power to medical equipment.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00815871021685	GS1

Premarket Submissions

Submission Number	Supplement Number
K100388	000