Slit Lamp HS-5000 HS-5000(LED)

GUDID 08800019600046

-. Magnfication : 5 position rotation drum -. Lamp : LED Lamp ( 10V 4.4W)

Huvitz Co., Ltd.

Ophthalmic slit lamp, examination

• Primary Device ID: 08800019600046
• NIH Device Record Key: e107242b-cac1-44e4-b968-c4e29c85eef3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Slit Lamp HS-5000
• Version Model Number: HS-5000(LED)
• Catalog Number: HS-5000(LED)
• Company DUNS: 688154202
• Company Name: Huvitz Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +82314289100
• Email: svc@huvitz.com
• Phone: +82314289100
• Email: svc@huvitz.com
• Phone: +82314289100
• Email: svc@huvitz.com
• Phone: +82314289100
• Email: svc@huvitz.com
• Phone: +82314289100
• Email: svc@huvitz.com
• Phone: +82314289100
• Email: svc@huvitz.com
• Phone: +82314289100
• Email: svc@huvitz.com
• Phone: +82314289100
• Email: svc@huvitz.com
• Phone: +82314289100
• Email: svc@huvitz.com
• Phone: +82314289100
• Email: svc@huvitz.com
• Phone: +82314289100
• Email: svc@huvitz.com
• Phone: +82314289100
• Email: svc@huvitz.com
• Phone: +82314289100
• Email: svc@huvitz.com
• Phone: +82314289100
• Email: svc@huvitz.com
• Phone: +82314289100
• Email: svc@huvitz.com
• Phone: +82314289100
• Email: svc@huvitz.com
• Phone: +82314289100
• Email: svc@huvitz.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800019600046 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K073190

FDA Product Code

• HJO: Biomicroscope, Slit-Lamp, Ac-Powered

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-05-17
• Device Publish Date: 2019-05-09

On-Brand Devices [Slit Lamp HS-5000]

• 08800019600114: -. Magnfication : 3 position rotation drum -. Lamp : LED Lamp ( 10V 4.4W)
• 08800019600107: " -. Magnfication : 3 position rotation drum -. Lamp : Halogen Bulb ( 12V 30W )"
• 08800019600046: -. Magnfication : 5 position rotation drum -. Lamp : LED Lamp ( 10V 4.4W)
• 08800019600008: -. Magnfication : 5 position rotation drum -. Lamp : Halogen Bulb ( 12V 30W )