VISERA ELITE III VIDEO SYSTEM CENTER N6158033

GUDID 04953170433313

OLYMPUS MEDICAL SYSTEMS CORP.

Endoscopic video image processing unit

• Primary Device ID: 04953170433313
• NIH Device Record Key: d4451b7d-f317-4521-9b90-ea7d01b5eff2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VISERA ELITE III VIDEO SYSTEM CENTER
• Version Model Number: OLYMPUS OTV-S700
• Catalog Number: N6158033
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04953170433313 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242067

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-04-25
• Device Publish Date: 2025-04-17

Devices Manufactured by OLYMPUS MEDICAL SYSTEMS CORP.

• 04953170430268 - 4K Camera Head: 2025-04-25
• 04953170433313 - VISERA ELITE III VIDEO SYSTEM CENTER: 2025-04-25
• 04953170433313 - VISERA ELITE III VIDEO SYSTEM CENTER: 2025-04-25
• 04953170433412 - VISERA ELITE III LED LIGHT SOURCE: 2025-04-25
• 04953170445453 - OTV-S700 UPGRADE PACK 3D: 2025-04-25
• 04953170467271 - PROBE DRIVING UNIT: 2025-04-24
• 04953170431760 - EVIS EUS ENDOSCOPIC ULTRASOUND CENTER: 2025-04-11
• 04953170431883 - CHE SOFTWARE OPTION: 2025-04-11
• 04953170431890 - ELST SOFTWARE OPTION: 2025-04-11