Remote control unit

GUDID 04953170305528

"MAJ-898 REMOTE CONTROL FOR OEP-3/4/5"

OLYMPUS MEDICAL SYSTEMS CORP.

Endoscopic device remote control

• Primary Device ID: 04953170305528
• NIH Device Record Key: bd6ce5ed-7434-4f5b-9565-c5a8cb81cff1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Remote control unit
• Version Model Number: MAJ-898
• Company DUNS: 711789789
• Company Name: OLYMPUS MEDICAL SYSTEMS CORP.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• Serial Number: false
• 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	04953170305528 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K951994

FDA Product Code

• IYO: System, imaging, pulsed echo, ultrasonic
• KQM: Camera, Surgical And Accessories

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: 2019-07-18
• Device Publish Date: 2016-09-21

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