4K Camera Head N6154740

GUDID 04953170430268

OLYMPUS MEDICAL SYSTEMS CORP.

Endoscope video camera

• Primary Device ID: 04953170430268
• NIH Device Record Key: df80c420-ee3e-4130-b749-287d55499e2d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 4K Camera Head
• Version Model Number: OLYMPUS CH-S700-XZ-EA
• Catalog Number: N6154740
• 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	04953170430268 [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: true
• Device Is Sterile: false

[04953170430268]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[04953170430268]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[04953170430268]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[04953170430268]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[04953170430268]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[04953170430268]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

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

On-Brand Devices [4K Camera Head]

• 04953170375552: OLYMPUS CH-S400-XZ-EA
• 04953170374609: OLYMPUS CH-S400-XZ-EB
• 04953170430268: OLYMPUS CH-S700-XZ-EA