SonoSurg Transducer

GUDID 14953170142625

OLYMPUS MEDICAL SYSTEMS CORP.

Soft-tissue ultrasonic surgical system

• Primary Device ID: 14953170142625
• NIH Device Record Key: c9411b8d-6b7b-4654-91fb-3402d2423b31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SonoSurg Transducer
• Version Model Number: SonoSurg-T2H-C
• Company DUNS: 711789789
• Company Name: OLYMPUS MEDICAL SYSTEMS CORP.
• Device Count: 1
• DM Exempt: true
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04953170142628 [Primary]
GS1	14953170142625 [Package]; Contains: 04953170142628; 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: true
• Device Is Sterile: false

[14953170142625]

Moist Heat or Steam Sterilization

[14953170142625]

Moist Heat or Steam Sterilization

[14953170142625]

Moist Heat or Steam Sterilization

[14953170142625]

Moist Heat or Steam Sterilization

[14953170142625]

Moist Heat or Steam Sterilization

[14953170142625]

Moist Heat or Steam Sterilization

[14953170142625]

Moist Heat or Steam Sterilization

[14953170142625]

Moist Heat or Steam Sterilization

[14953170142625]

Moist Heat or Steam Sterilization

[14953170142625]

Moist Heat or Steam Sterilization

[14953170142625]

Moist Heat or Steam Sterilization

[14953170142625]

Moist Heat or Steam Sterilization

[14953170142625]

Moist Heat or Steam Sterilization

[14953170142625]

Moist Heat or Steam Sterilization

[14953170142625]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2018-10-08
• Device Publish Date: 2017-10-06

On-Brand Devices [SonoSurg Transducer]

• 14953170182973: SonoSurg-T2L-GE-C
• 14953170142625: SonoSurg-T2H-C
• 14953170062602: SonoSurg-T2H