Foot Swtich for LUS-2

GUDID 04953170138553

MAJ-1001 FOOTSWITCH FOR LUS-2

OLYMPUS MEDICAL SYSTEMS CORP.

Foot-switch, electrical

• Primary Device ID: 04953170138553
• NIH Device Record Key: 121b0008-e283-43c5-8bbf-ef1b779647d5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Foot Swtich for LUS-2
• Version Model Number: MAJ-1001
• 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	04953170138553 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K873367

FDA Product Code

• FEO: Lithotriptor, ultrasonic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-21

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• 04953170467295 - ULTRASONIC PROBE: 2025-09-26
• 04953170467301 - ULTRASONIC PROBE: 2025-09-26
• 14953170458375 - Single Use Aspiration Needle NA-201SX-4021: 2025-08-22