Binocular Indirect Ophthalmoscope

Basic Information

• Brand Name: Binocular Indirect Ophthalmoscope
• Primary DI: 04571328642167
• Version / Model: IO-a LED BP-II SET2
• Catalog Number: 108851
• Company Name: NEITZ INSTRUMENTS CO.,LTD.
• Labeler DUNS: 690582325
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-10-31
• Public Version: 2
• Public Version Date: 2021-02-19
• Public Version Status: Update
• Public Device Record Key: 30b2166d-0ad6-4778-9806-5e017a8bdb93

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: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
HLJ	Ophthalmoscope, Battery-Powered	Ophthalmic	886.1570	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46790	Indirect binocular ophthalmoscope	An electrically-powered, head-worn, ophthalmic instrument designed to be held arm’s length from the patient to examine the interior of the eye and related structures [e.g., fundus (retina), cornea, aqueous, lens, vitreous] using the examiner’s two eyes simultaneously (stereoscopic vision). It is intended to provide a wide field of view and produce an inverted (reversed) image of approximately 2 to 5 times magnification. It typically consists of a main light to illuminate the interior of the eyeball, lenses, filters and an illuminator beam to eliminate reflexes; it can be mounted on a headband or spectacle frames.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04571328642167	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -10 – 55 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 10 – 95 Percent (%) Relative Humidity
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 500 – 1060 millibar
• Type: Handling Environment Temperature
• Temperature Range: 10 – 35 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 30 – 90 Percent (%) Relative Humidity
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 800 – 1060 millibar