UniARM

GUDID 04589698450022

The UniARM is for use in holding medical devices such a endoscopes and retractors in surgery.

MITAKA KOHKI CO., LTD.

Surgical instrument assist arm system, power-adjusted

• Primary Device ID: 04589698450022
• NIH Device Record Key: 52f9e5e6-fcdf-41d4-9054-f199657116f5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UniARM
• Version Model Number: UA1
• Company DUNS: 692666613
• Company Name: MITAKA KOHKI CO., LTD.
• 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: false
• Serial Number: true
• Manufacturing Date: false
• 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	04589698450022 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090792

FDA Product Code

• GWG: Endoscope, Neurological

Sterilization

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

[04589698450022]

Moist Heat or Steam Sterilization;Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-03-11
• Device Publish Date: 2016-10-17

Devices Manufactured by MITAKA KOHKI CO., LTD.

• 04589698450602 - 4K3D Video Microscope HawkSight: 2022-12-08
• 04589698450251 - Surgical Microscope MM90/YOH: 2022-12-05
• 04589698450268 - Surgical Microscope MM80/YOH: 2022-12-05
• 04589698450275 - Surgical Microscope MM80/SOH: 2022-12-05
• 04589698450534 - Surgical Microscope MM80/SS1: 2022-12-05
• 04589698450541 - Surgical Microscope MM51/SS1: 2022-12-05
• 04589698450558 - Surgical Microscope MM90/SS1: 2022-12-05
• 04589698450572 - Surgical Microscope MM90/SOH: 2022-12-05