PROBE HOLDER

GUDID 04953170053573

OLYMPUS MEDICAL SYSTEMS CORP.

Surgical instrument assist arm system, manually-adjusted

• Primary Device ID: 04953170053573
• NIH Device Record Key: 3aa0f9b9-7586-4a65-a6a7-ac9df24e67d5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PROBE HOLDER
• Version Model Number: MH-245
• 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: false
• Manufacturing Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04953170053573 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K944610

FDA Product Code

• ITX: Transducer, Ultrasonic, Diagnostic

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[04953170053573]

High-level Disinfectant;Ethylene Oxide

[04953170053573]

High-level Disinfectant;Ethylene Oxide

[04953170053573]

High-level Disinfectant;Ethylene Oxide

[04953170053573]

High-level Disinfectant;Ethylene Oxide

[04953170053573]

High-level Disinfectant;Ethylene Oxide

[04953170053573]

High-level Disinfectant;Ethylene Oxide

[04953170053573]

High-level Disinfectant;Ethylene Oxide

[04953170053573]

High-level Disinfectant;Ethylene Oxide

[04953170053573]

High-level Disinfectant;Ethylene Oxide

[04953170053573]

High-level Disinfectant;Ethylene Oxide

[04953170053573]

High-level Disinfectant;Ethylene Oxide

[04953170053573]

High-level Disinfectant;Ethylene Oxide

[04953170053573]

High-level Disinfectant;Ethylene Oxide

[04953170053573]

High-level Disinfectant;Ethylene Oxide

[04953170053573]

High-level Disinfectant;Ethylene Oxide

[04953170053573]

High-level Disinfectant;Ethylene Oxide

[04953170053573]

High-level Disinfectant;Ethylene Oxide

[04953170053573]

High-level Disinfectant;Ethylene Oxide

[04953170053573]

High-level Disinfectant;Ethylene Oxide

[04953170053573]

High-level Disinfectant;Ethylene Oxide

[04953170053573]

High-level Disinfectant;Ethylene Oxide

[04953170053573]

High-level Disinfectant;Ethylene Oxide

[04953170053573]

High-level Disinfectant;Ethylene Oxide

[04953170053573]

High-level Disinfectant;Ethylene Oxide

[04953170053573]

High-level Disinfectant;Ethylene Oxide

[04953170053573]

High-level Disinfectant;Ethylene Oxide

[04953170053573]

High-level Disinfectant;Ethylene Oxide

[04953170053573]

High-level Disinfectant;Ethylene Oxide

[04953170053573]

High-level Disinfectant;Ethylene Oxide

[04953170053573]

High-level Disinfectant;Ethylene Oxide

[04953170053573]

High-level Disinfectant;Ethylene Oxide

[04953170053573]

High-level Disinfectant;Ethylene Oxide

[04953170053573]

High-level Disinfectant;Ethylene Oxide

[04953170053573]

High-level Disinfectant;Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-01-07
• Device Publish Date: 2021-12-30

Devices Manufactured by OLYMPUS MEDICAL SYSTEMS CORP.

• 04953170431760 - EVIS EUS ENDOSCOPIC ULTRASOUND CENTER: 2025-04-11
• 04953170431883 - CHE SOFTWARE OPTION: 2025-04-11
• 04953170431890 - ELST SOFTWARE OPTION: 2025-04-11
• 04953170431906 - SWQ SOFTWARE OPTION: 2025-04-11
• 14953170466134 - Single Use Retrieval Basket V: 2025-04-02
• 14953170466141 - Single Use Retrieval Basket V: 2025-04-02
• 14953170466158 - Single Use Retrieval Basket V: 2025-04-02
• 14953170466165 - Single Use Retrieval Basket V: 2025-04-02