SONICBEAT 5 mm, 10 cm, Inline Grip

GUDID 14953170308977

OLYMPUS MEDICAL SYSTEMS CORP.

Soft-tissue ultrasonic surgical system handpiece tip, single-use Soft-tissue ultrasonic surgical system holder/tip, single-use Soft-tissue ultrasonic surgical system holder/tip, single-use Soft-tissue ultrasonic surgical system holder/tip, single-use Soft-tissue ultrasonic surgical system holder/tip, single-use Soft-tissue ultrasonic surgical system holder/tip, single-use Soft-tissue ultrasonic surgical system holder/tip, single-use Soft-tissue ultrasonic surgical system holder/tip, single-use Soft-tissue ultrasonic surgical system holder/tip, single-use Soft-tissue ultrasonic surgical system holder/tip, single-use Soft-tissue ultrasonic surgical system holder/tip, single-use Soft-tissue ultrasonic surgical system holder/tip, single-use Soft-tissue ultrasonic surgical system holder/tip, single-use Soft-tissue ultrasonic surgical system holder/tip, single-use Soft-tissue ultrasonic surgical system holder/tip, single-use Soft-tissue ultrasonic surgical system holder/tip, single-use Soft-tissue ultrasonic surgical system holder/tip, single-use Soft-tissue ultrasonic surgical system holder/tip, single-use Soft-tissue ultrasonic surgical system holder/tip, single-use Soft-tissue ultrasonic surgical system holder/tip, single-use Soft-tissue ultrasonic surgical system holder/tip, single-use Soft-tissue ultrasonic surgical system holder/tip, single-use Soft-tissue ultrasonic surgical system holder/tip, single-use Soft-tissue ultrasonic surgical system holder/tip, single-use Soft-tissue ultrasonic surgical system holder/tip, single-use Soft-tissue ultrasonic surgical system holder/tip, single-use Soft-tissue ultrasonic surgical system holder/tip, single-use Soft-tissue ultrasonic surgical system holder/tip, single-use Soft-tissue ultrasonic surgical system holder/tip, single-use Soft-tissue ultrasonic surgical system holder/tip, single-use Soft-tissue ultrasonic surgical system holder/tip, single-use Soft-tissue ultrasonic surgical system holder/tip, single-use Soft-tissue ultrasonic surgical system holder/tip, single-use Soft-tissue ultrasonic surgical system holder/tip, single-use Soft-tissue ultrasonic surgical system holder/tip, single-use

• Primary Device ID: 14953170308977
• NIH Device Record Key: c5adbc6d-446a-4a62-9c15-cf3639c4c02f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SONICBEAT 5 mm, 10 cm, Inline Grip
• Version Model Number: SB-0510IC
• 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
• 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	04953170308970 [Primary]
GS1	14953170308977 [Package]; Contains: 04953170308970; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• 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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-21

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