UPGRADE KIT FOR UCES-3(Version4)

GUDID 04953170328985

OLYMPUS MEDICAL SYSTEMS CORP.

Operating room audiovisual data/device management system application software Operating room audiovisual data/device management system application software Operating room audiovisual data/device management system application software Operating room audiovisual data/device management system application software Operating room audiovisual data/device management system application software Operating room audiovisual data/device management system application software Operating room audiovisual data/device management system application software Operating room audiovisual data/device management system application software Operating room audiovisual data/device management system application software Operating room audiovisual data/device management system application software Operating room audiovisual data/device management system application software Operating room audiovisual data/device management system application software Operating room audiovisual data/device management system application software Operating room audiovisual data/device management system application software Operating room audiovisual data/device management system application software Operating room audiovisual data/device management system application software Operating room audiovisual data/device management system application software Operating room audiovisual data/device management system application software Operating room audiovisual data/device management system application software Operating room audiovisual data/device management system application software Operating room audiovisual data/device management system application software Operating room audiovisual data/device management system application software Operating room audiovisual data/device management system application software Operating room audiovisual data/device management system application software Operating room audiovisual data/device management system application software Operating room audiovisual data/device management system application software Operating room audiovisual data/device management system application software Operating room audiovisual data/device management system application software

• Primary Device ID: 04953170328985
• NIH Device Record Key: 885e626a-eace-485a-8732-a8f0d461bb64
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UPGRADE KIT FOR UCES-3(Version4)
• Version Model Number: MAJ-2051
• 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: 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04953170328985 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-12-27
• Device Publish Date: 2021-12-17

Devices Manufactured by OLYMPUS MEDICAL SYSTEMS CORP.

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• 14953170460064 - Single Use Biliary Drainage Stent V: 2024-04-02
• 14953170460088 - Single Use Biliary Drainage Stent V: 2024-04-02
• 14953170460101 - Single Use Biliary Drainage Stent V: 2024-04-02
• 14953170460132 - Single Use Biliary Drainage Stent V: 2024-04-02
• 14953170460330 - Single Use Biliary Drainage Stent V: 2024-04-02
• 14953170460378 - Single Use Biliary Drainage Stent V: 2024-04-02
• 14953170460613 - Single Use Biliary Drainage Stent V: 2024-04-02