THUNDERBEAT Open Fine Jaw Type X N5768340

GUDID 14953170435826

OLYMPUS MEDICAL SYSTEMS CORP.

Endoscopic electrosurgical/ultrasonic surgical system instrument

• Primary Device ID: 14953170435826
• NIH Device Record Key: 3e07f3a5-0cff-4fb3-934f-f7b8fd87198b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: THUNDERBEAT Open Fine Jaw Type X
• Version Model Number: TB-0009OFX
• Catalog Number: N5768340
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)401-1086
• Email: xx@xx.xx
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• Phone: +1(800)401-1086
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• Phone: +1(800)401-1086
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• Phone: +1(800)401-1086
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• Phone: +1(800)401-1086
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• Phone: +1(800)401-1086
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• Phone: +1(800)401-1086
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Device Identifiers

Device Issuing Agency	Device ID
GS1	04953170435829 [Primary]
GS1	14953170435826 [Package]; Contains: 04953170435829; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211838

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-17
• Device Publish Date: 2023-08-09

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• 04953170467332 - AIR/WATER VALVE MAJ-1444: 2025-10-03
• 04953170467349 - ULTRASONIC GASTROVIDEOSCOPE OLYMPUS GF TYPE UE160-AL5: 2025-10-03
• 04953170467356 - EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE OLYMPUS GF TYPE UCT180: 2025-10-03
• 04953170467295 - ULTRASONIC PROBE: 2025-09-26
• 04953170467301 - ULTRASONIC PROBE: 2025-09-26
• 14953170458375 - Single Use Aspiration Needle NA-201SX-4021: 2025-08-22