THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 25cm R5001009

GUDID 14953170440004

OLYMPUS MEDICAL SYSTEMS CORP.

Endoscopic electrosurgical/ultrasonic surgical system instrument

• Primary Device ID: 14953170440004
• NIH Device Record Key: 63d8835a-e14b-48a5-84ec-346720de0571
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 25cm
• Version Model Number: TB2-0525FC
• Catalog Number: R5001009
• 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: false
• 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
• 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	04953170440007 [Primary]
GS1	14953170440004 [Package]; Contains: 04953170440007; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K252150

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: 2025-12-12
• Device Publish Date: 2025-12-04

Devices Manufactured by OLYMPUS MEDICAL SYSTEMS CORP.

• 04953170421815 - Reusable Cordless Transducer: 2025-12-12
• 14953170439992 - THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 20cm: 2025-12-12
• 14953170440004 - THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 25cm: 2025-12-12
• 14953170440004 - THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 25cm: 2025-12-12
• 14953170440011 - THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 35cm: 2025-12-12
• 14953170440028 - THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 45cm: 2025-12-12
• 04953170442353 - ULTRASONIC BIPOLAR GENERATOR: 2025-12-12 "This product is Version 2. A Version 1 product with the same name exists."
• 04953170442445 - Update Tool for USG-410: 2025-12-12
• 14953170459204 - Single-use Fine Needle Biopsy (FNB) Device NA-U210H: 2025-12-10