SonoSurg Generator Set

GUDID 14953170170895

OLYMPUS MEDICAL SYSTEMS CORP.

Soft-tissue ultrasonic surgical system

• Primary Device ID: 14953170170895
• NIH Device Record Key: 102d13cc-fb35-4ddc-80e0-0a096bb3d9ac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SonoSurg Generator Set
• Version Model Number: SonoSurg-G2 Set
• 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04953170170898 [Primary]
GS1	14953170170895 [Package]; Contains: 04953170170898; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050885

FDA Product Code

• LFL: Instrument, ultrasonic surgical

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-10-06

Devices Manufactured by OLYMPUS MEDICAL SYSTEMS CORP.

• 04953170452932 - TRACHEAL INTUBATION FIBERSCOPE: 2024-04-22
• 14953170460064 - Single Use Biliary Drainage Stent V: 2024-04-02
• 14953170460088 - Single Use Biliary Drainage Stent V: 2024-04-02
• 14953170460101 - Single Use Biliary Drainage Stent V: 2024-04-02
• 14953170460132 - Single Use Biliary Drainage Stent V: 2024-04-02
• 14953170460330 - Single Use Biliary Drainage Stent V: 2024-04-02
• 14953170460378 - Single Use Biliary Drainage Stent V: 2024-04-02
• 14953170460613 - Single Use Biliary Drainage Stent V: 2024-04-02