THUNDERBEAT Open Extended Jaw

GUDID 14953170343312

OLYMPUS MEDICAL SYSTEMS CORP.

Electrosurgical handpiece, single-use

• Primary Device ID: 14953170343312
• NIH Device Record Key: c28cdced-6603-4b4d-b72e-1ed0444220a9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: THUNDERBEAT Open Extended Jaw
• Version Model Number: TB-0920OE
• 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
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Device Identifiers

Device Issuing Agency	Device ID
GS1	04953170343315 [Primary]
GS1	14953170343312 [Package]; Contains: 04953170343315; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132703
• Premarket Notification: K211838

FDA Product Code

• LFL: Instrument, ultrasonic surgical

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-21

On-Brand Devices [THUNDERBEAT Open Extended Jaw]

• 14953170343312: TB-0920OE
• 14953170343305: TB-0920OE