COMPASS

Basic Information

• Brand Name: COMPASS
• Primary DI: 08053677040048
• Version / Model: COMPASS
• Catalog Number: AMGSDME01
• Company Name: CENTERVUE SPA
• Labeler DUNS: 338702316
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-03
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 0327c702-73fb-41a9-b2db-cee70200f39c

Device Description

COMPASS is a scanning ophthalmoscope combined with an automatic perimeter that allows the acquisition of images of the retina, as well as the measurement of retinal threshold sensitivity and the analysis of fixation..

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: Yes
• 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
HPT	Perimeter, Automatic, Ac-Powered	Ophthalmic	886.1605	1

GMDN Terms

Code	Name	Definition	Implantable	Status
16918	Perimeter, automatic	A mains electricity (AC-powered), automatically operated, diagnostic, ophthalmic instrument intended for assessing the extent of the patient's peripheral visual field. Small luminous points (spots) are automatically displayed in various random positions and patient response is automatically recorded. The print-out (chart) then shows the resulting curve of the visual field. Such types include Humphrey perimeters.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08053677040048	GS1

Premarket Submissions

Submission Number	Supplement Number
K150320	000