PROBE DRIVING UNIT

GUDID 04953170311192

OLYMPUS MEDICAL SYSTEMS CORP.

General-purpose ultrasound imaging system

• Primary Device ID: 04953170311192
• NIH Device Record Key: e126f244-3cbb-4f9e-8daa-20e6d5f657b4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PROBE DRIVING UNIT
• Version Model Number: MAJ-1720
• Company DUNS: 711789789
• Company Name: OLYMPUS MEDICAL SYSTEMS CORP.
• 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: 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

Customer Support Contacts

• Phone: +1(800)401-1086
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	04953170311192 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K011886

FDA Product Code

• FET: Endoscopic video imaging system/component, gastroenterology-urology

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-10-06

On-Brand Devices [PROBE DRIVING UNIT]

• 04953170355684: MAJ-1720 Probe driver for all probes
• 04953170311192: MAJ-1720
• 04953170136634: MAJ-935