Universal 10-15mm pediatric

GUDID 04589698450473

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

MITAKA KOHKI CO., LTD.

Surgical instrument assist arm system, power-adjusted

• Primary Device ID: 04589698450473
• NIH Device Record Key: 9a8f9032-4073-4c97-a5f4-4b2b6e02b7e2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Universal 10-15mm pediatric
• Version Model Number: PS-BU-046
• 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	04589698450473 [Primary]

FDA Product Code

• GWG: Endoscope, Neurological

Sterilization

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

[04589698450473]

Moist Heat or Steam Sterilization;Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-03-13
• 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