THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 20cm R5001008

GUDID 14953170439992

OLYMPUS MEDICAL SYSTEMS CORP.

Endoscopic electrosurgical/ultrasonic surgical system instrument

• Primary Device ID: 14953170439992
• NIH Device Record Key: 9f82e14f-bb0b-4bd4-8ef1-4926065792ec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 20cm
• Version Model Number: TB2-0520FC
• Catalog Number: R5001008
• 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
• 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
• 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	04953170439995 [Primary]
GS1	14953170439992 [Package]; Contains: 04953170439995; 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

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• 14953170439992 - THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 20cm: 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
• 14953170440011 - THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 35cm: 2025-12-12
• 14953170440028 - THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 45cm: 2025-12-12