UA Endo holder 10-15mm

GUDID 04589698450497

This device is designed to be used with the endoscope holder "UniARM" manufactured by Mitaka Kohki Co., Ltd.

MITAKA KOHKI CO., LTD.

Surgical instrument assist arm system, power-adjusted

• Primary Device ID: 04589698450497
• NIH Device Record Key: 80130370-897d-4ae5-91cb-477c754286f9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UA Endo holder 10-15mm
• Version Model Number: UH-1015U
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04589698450497 [Primary]

FDA Product Code

• GCJ: Laparoscope, General & Plastic Surgery

Sterilization

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

[04589698450497]

Ethylene Oxide;Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-03-11
• Device Publish Date: 2019-02-06

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