MEDICAL CONTROL UNIT FOR ENDOSURGERY

GUDID 04953170286001

OLYMPUS MEDICAL SYSTEMS CORP.

Medical image management system Operating room audiovisual data/device management system Operating room audiovisual data/device management system Operating room audiovisual data/device management system Operating room audiovisual data/device management system Operating room audiovisual data/device management system Operating room audiovisual data/device management system Operating room audiovisual data/device management system Operating room audiovisual data/device management system Operating room audiovisual data/device management system Operating room audiovisual data/device management system Operating room audiovisual data/device management system Operating room audiovisual data/device management system Operating room audiovisual data/device management system Operating room audiovisual data/device management system Operating room audiovisual data/device management system Operating room audiovisual data/device management system Operating room audiovisual data/device management system Operating room audiovisual data/device management system Operating room audiovisual data/device management system Operating room audiovisual data/device management system Operating room audiovisual data/device management system Operating room audiovisual data/device management system Operating room audiovisual data/device management system Operating room audiovisual data/device management system Operating room audiovisual data/device management system Operating room audiovisual data/device management system Operating room audiovisual data/device management system Operating room audiovisual data/device management system Operating room audiovisual data/device management system Operating room audiovisual data/device management system Operating room audiovisual data/device management system Operating room audiovisual data/device management system

• Primary Device ID: 04953170286001
• NIH Device Record Key: 5052ce3e-9bab-4f61-a4e0-06ae17301788
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MEDICAL CONTROL UNIT FOR ENDOSURGERY
• Version Model Number: UCES-3
• 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
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	04953170286001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121701

FDA Product Code

• ODA: endoscopic central control unit

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

On-Brand Devices [MEDICAL CONTROL UNIT FOR ENDOSURGERY]

• 04953170286018: UCES-3
• 04953170286001: UCES-3