Amoils Epithelial Scrubber AM3DMHANDLE

GUDID 00628693343237

Amoils Power Handle

Innova Medical Ophthalmics Inc

Corneal bur system, battery-powered

• Primary Device ID: 00628693343237
• NIH Device Record Key: d0e67ad5-a311-4dca-b968-d9c7ed0f56fb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Amoils Epithelial Scrubber
• Version Model Number: Amoils Power Handle
• Catalog Number: AM3DMHANDLE
• 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	00628693343237 [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: 2025-03-10
• Device Publish Date: 2025-02-28

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)
• 00628693343268: Amoils Handle Charger (230V)
• 00628693343251: Amoils Handle Charger (120V)
• 00628693343244: Amoils Neck Mount
• 00628693343237: Amoils Power Handle