Amoils Epithelial Scrubber AM1EXPH1

GUDID 00628693343107

Amoils Power Handle, Neck & Charger - Kit (230V)

Innova Medical Ophthalmics Inc

Corneal bur system, battery-powered

• Primary Device ID: 00628693343107
• NIH Device Record Key: 97bc67ba-872c-4bd7-aa62-3ac9d906aed2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Amoils Epithelial Scrubber
• Version Model Number: Amoils Power Handle, Neck & Charger - Kit (230V)
• Catalog Number: AM1EXPH1
• Company DUNS: 249464702
• Company Name: Innova Medical Ophthalmics Inc
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00628693343107 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K962989

FDA Product Code

• HOG: Burr, Corneal, Battery-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: 2024-11-08
• Device Publish Date: 2024-10-31

On-Brand Devices [Amoils Epithelial Scrubber]

• 00628693343053: Amoils Epithelial Scrubber - Hyperopic XL Pack of 25
• 00628693343046: Amoils Epithelial Scrubber - Hyperopic Pack of 25
• 00628693343039: Amoils Epithelial Scrubber - Myopic Pack of 25
• 00628693343107: Amoils Power Handle, Neck & Charger - Kit (230V)
• 00628693343091: Amoils Power Handle, Neck & Charger - Kit (120V)