MEDINAUT MAX Pro

GUDID 08800038055605

MEDINAUT MAX Pro handpiece

IMEDICOM CO., LTD.

Bone/joint surgical power tool motorized handpiece/set, electric, reusable

• Primary Device ID: 08800038055605
• NIH Device Record Key: e1679621-4b0d-45ba-8db4-1aec2ef2d5f4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MEDINAUT MAX Pro
• Version Model Number: BSH-100
• Company DUNS: 690340653
• Company Name: IMEDICOM CO., LTD.
• 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: 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	08800038055605 [Primary]

FDA Product Code

• KIJ: Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[08800038055605]

Moist Heat or Steam Sterilization

[08800038055605]

Moist Heat or Steam Sterilization

[08800038055605]

Moist Heat or Steam Sterilization

[08800038055605]

Moist Heat or Steam Sterilization

[08800038055605]

Moist Heat or Steam Sterilization

[08800038055605]

Moist Heat or Steam Sterilization

[08800038055605]

Moist Heat or Steam Sterilization

[08800038055605]

Moist Heat or Steam Sterilization

[08800038055605]

Moist Heat or Steam Sterilization

[08800038055605]

Moist Heat or Steam Sterilization

[08800038055605]

Moist Heat or Steam Sterilization

[08800038055605]

Moist Heat or Steam Sterilization

[08800038055605]

Moist Heat or Steam Sterilization

[08800038055605]

Moist Heat or Steam Sterilization

[08800038055605]

Moist Heat or Steam Sterilization

[08800038055605]

Moist Heat or Steam Sterilization

[08800038055605]

Moist Heat or Steam Sterilization

[08800038055605]

Moist Heat or Steam Sterilization

[08800038055605]

Moist Heat or Steam Sterilization

[08800038055605]

Moist Heat or Steam Sterilization

[08800038055605]

Moist Heat or Steam Sterilization

[08800038055605]

Moist Heat or Steam Sterilization

[08800038055605]

Moist Heat or Steam Sterilization

[08800038055605]

Moist Heat or Steam Sterilization

[08800038055605]

Moist Heat or Steam Sterilization

[08800038055605]

Moist Heat or Steam Sterilization

[08800038055605]

Moist Heat or Steam Sterilization

[08800038055605]

Moist Heat or Steam Sterilization

[08800038055605]

Moist Heat or Steam Sterilization

[08800038055605]

Moist Heat or Steam Sterilization

[08800038055605]

Moist Heat or Steam Sterilization

[08800038055605]

Moist Heat or Steam Sterilization

[08800038055605]

Moist Heat or Steam Sterilization

[08800038055605]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-04-23
• Device Publish Date: 2024-04-15

Devices Manufactured by IMEDICOM CO., LTD.

• 08800038060265 - EZX: 2025-07-25 EZX (EZX Tray)
• 08800038060272 - EZX: 2025-07-25 EZX (Tray Cover)
• 08800038060289 - EZX: 2025-07-25 EZX (Lower Tray)
• 08800038060296 - EZX: 2025-07-25 EZX (Upper Tray)
• 08800038060302 - EZX: 2025-07-25 EZX(Main Tray)
• 08800038060142 - MEDINAUT-Ix: 2025-07-23 Cannula(132mm) and Trocar type Needle
• 08800038060159 - MEDINAUT-Ix: 2025-07-23 Cannula(132mm) and Bevel type Needle
• 08800038060166 - MEDINAUT-Ix: 2025-07-23 Cannula(132mm) and Diamond type Needle