AIT-350W

GUDID 00852683007230

AIT-350W INSTRUMENT TABLE-240 VOLT; AC-Powered Ophthalmic Instrument Table

TOPCON MEDICAL SYSTEMS, INC.

Ophthalmic instrument table, line-powered

• Primary Device ID: 00852683007230
• NIH Device Record Key: 2386f55a-b39c-4320-8110-6a2a20e1f98c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AIT-350W
• Version Model Number: 25043-22-001
• 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	00852683007230 [Primary]

FDA Product Code

• HRJ: Table, Instrument, 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 [AIT-350W]

• 08526830083614: AIT-350W INSTRUMENT TABLE-240 VOLT; AC-Powered Ophthalmic Instrument Table
• 08526830083607: AIT-350W INSTRUMENT TABLE-110/120 VOLT; AC-Powered Ophthalmic Instrument Table
• 00852683007230: AIT-350W INSTRUMENT TABLE-240 VOLT; AC-Powered Ophthalmic Instrument Table
• 00852683007223: AIT-350W INSTRUMENT TABLE-110/120 VOLT; AC-Powered Ophthalmic Instrument Table