Perimeter

Basic Information

• Brand Name: Perimeter
• Primary DI: 06973211070534
• Version / Model: SK-850A
• Company Name: CHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTD
• Labeler DUNS: 545824560
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-07-02
• Public Version: 1
• Public Version Date: 2020-07-10
• Public Version Status: New
• Public Device Record Key: e33de0d3-815e-4aff-82c1-4cafa5ba0620

Device Description

It is an AC-powered or manual device intended to determine the extent of the peripheral visual field of a patient. The device projects light on various points of a curved surface, and the patient indicates whether he or she sees the light.

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: Yes
• 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
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	06973211070534	GS1