THUNDERBEAT Transducer

GUDID 14953170306775

OLYMPUS MEDICAL SYSTEMS CORP.

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• Primary Device ID: 14953170306775
• NIH Device Record Key: 8dd9e6e3-328e-4d53-8364-d9bf6d58e7f9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: THUNDERBEAT Transducer
• Version Model Number: TD-TB400
• 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: 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
• 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
• 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	04953170306778 [Primary]
GS1	14953170306775 [Package]; Contains: 04953170306778; Package: [1 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: true
• Device Is Sterile: false

[14953170306775]

Moist Heat or Steam Sterilization

[14953170306775]

Moist Heat or Steam Sterilization

[14953170306775]

Moist Heat or Steam Sterilization

[14953170306775]

Moist Heat or Steam Sterilization

[14953170306775]

Moist Heat or Steam Sterilization

[14953170306775]

Moist Heat or Steam Sterilization

[14953170306775]

Moist Heat or Steam Sterilization

[14953170306775]

Moist Heat or Steam Sterilization

[14953170306775]

Moist Heat or Steam Sterilization

[14953170306775]

Moist Heat or Steam Sterilization

[14953170306775]

Moist Heat or Steam Sterilization

[14953170306775]

Moist Heat or Steam Sterilization

[14953170306775]

Moist Heat or Steam Sterilization

[14953170306775]

Moist Heat or Steam Sterilization

[14953170306775]

Moist Heat or Steam Sterilization

[14953170306775]

Moist Heat or Steam Sterilization

[14953170306775]

Moist Heat or Steam Sterilization

[14953170306775]

Moist Heat or Steam Sterilization

[14953170306775]

Moist Heat or Steam Sterilization

[14953170306775]

Moist Heat or Steam Sterilization

[14953170306775]

Moist Heat or Steam Sterilization

[14953170306775]

Moist Heat or Steam Sterilization

[14953170306775]

Moist Heat or Steam Sterilization

[14953170306775]

Moist Heat or Steam Sterilization

[14953170306775]

Moist Heat or Steam Sterilization

[14953170306775]

Moist Heat or Steam Sterilization

[14953170306775]

Moist Heat or Steam Sterilization

[14953170306775]

Moist Heat or Steam Sterilization

[14953170306775]

Moist Heat or Steam Sterilization

[14953170306775]

Moist Heat or Steam Sterilization

[14953170306775]

Moist Heat or Steam Sterilization

[14953170306775]

Moist Heat or Steam Sterilization

[14953170306775]

Moist Heat or Steam Sterilization

[14953170306775]

Moist Heat or Steam Sterilization

[14953170306775]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-21

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