Slit Lamp HS-5000

Basic Information

• Brand Name: Slit Lamp HS-5000
• Primary DI: 08800019600008
• Version / Model: HS-5000
• Catalog Number: HS-5000
• Company Name: Huvitz Co., Ltd.
• Labeler DUNS: 688154202
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-24
• Public Version: 6
• Public Version Date: 2022-12-20
• Public Version Status: Update
• Public Device Record Key: 3e666b47-e78a-45fa-ab3f-7cb5fc33535f

Device Description

-. Magnfication : 5 position rotation drum -. Lamp : Halogen Bulb ( 12V 30W )

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: 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
HJO	Biomicroscope, Slit-Lamp, Ac-Powered	Ophthalmic	886.1850	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35148	Ophthalmic examination slit lamp	An electrically-powered, ophthalmic, binocular microscope designed to examine the interior anatomy of the eye by viewing through the pupil; it is not dedicated to surgical procedures. It projects a narrow slit of light into the eye and resulting light reflections are detected obliquely with a travelling microscope to enable observation of the internal ocular structures. It is used to perform a variety of measurements [e.g., intraocular pressure (IOP) or tonometry, corneal thickness, anterior chamber depth] and to evaluate symptoms (e.g., eye itchiness, grittiness, pain, dry eyes, photophobia, and reduced visual acuity).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08800019600008	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K073190	000

Storage Conditions

• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 70 – 106 KiloPascal
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 70 – 106 KiloPascal
• Type: Handling Environment Humidity
• Temperature Range: -10 – 40 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: -10 – 40 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 30 – 75 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -10 – 40 Degrees Celsius