MAXUM

GUDID M737M53031

MAXUM CUSTOMIZATION SET BEADS

Ototronix, LLC

Partially-implantable middle ear implant system

• Primary Device ID: M737M53031
• NIH Device Record Key: 127792fc-59fe-45ec-8262-73ca2e2eb41a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MAXUM
• Version Model Number: M5303
• Company DUNS: 833067478
• Company Name: Ototronix, LLC
• 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: 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M737M53031 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P010023

FDA Product Code

• MPV: Implant, Hearing, Active, Middle Ear, Partially Implanted

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: 2022-04-06
• Device Publish Date: 2022-03-29

On-Brand Devices [MAXUM]

• M737M53031: MAXUM CUSTOMIZATION SET BEADS
• M737M31991: MAXUM IPC FIT DEMO
• M737M31101: MAXUM IPC REMAKE