MAXUM

GUDID M737M31101

MAXUM IPC REMAKE

Ototronix, LLC

Partially-implantable middle ear implant system Partially-implantable middle ear implant system Partially-implantable middle ear implant system Partially-implantable middle ear implant system Partially-implantable middle ear implant system Partially-implantable middle ear implant system Partially-implantable middle ear implant system Partially-implantable middle ear implant system Partially-implantable middle ear implant system Partially-implantable middle ear implant system Partially-implantable middle ear implant system Partially-implantable middle ear implant system Partially-implantable middle ear implant system Partially-implantable middle ear implant system Partially-implantable middle ear implant system

• Primary Device ID: M737M31101
• NIH Device Record Key: 9db9ff87-f7ad-4761-85d9-f185f32d98a1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MAXUM
• Version Model Number: M3110
• Company DUNS: 833067478
• Company Name: Ototronix, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• 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	M737M31101 [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