IS-5000

GUDID 00852683007148

IS-5000 INSTRUMENT STAND 110/120 VOLT; AC-Powered Ophthalmic Instrument Stand

TOPCON MEDICAL SYSTEMS, INC.

Static ophthalmic equipment stand, manually-adjusted

• Primary Device ID: 00852683007148
• NIH Device Record Key: b537c84c-c5c8-4188-b882-e37e365c44f2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IS-5000
• Version Model Number: 23070-11-001
• Company DUNS: 053547238
• Company Name: TOPCON MEDICAL SYSTEMS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852683007148 [Primary]

FDA Product Code

• HMF: Stand, Instrument, Ac-Powered, Ophthalmic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-05-25
• Device Publish Date: 2022-12-07

On-Brand Devices [IS-5000]

• 08526830083317: IS-5000 INSTRUMENT STAND 220 VOLT; AC-Powered Ophthalmic Instrument Stand
• 08526830083300: IS-5000 INSTRUMENT STAND 110/120 VOLT; AC-Powered Ophthalmic Instrument Stand
• 00852683007155: IS-5000 INSTRUMENT STAND 220 VOLT; AC-Powered Ophthalmic Instrument Stand
• 00852683007148: IS-5000 INSTRUMENT STAND 110/120 VOLT; AC-Powered Ophthalmic Instrument Stand