SONICFUSION 1910-2001

GUDID 07613252495086

Handpiece SonicPin

Stryker Trauma GmbH

Ultrasonic osteosynthesis system handpiece Bone pin ultrasonic osteosynthesis system handpiece Bone pin ultrasonic osteosynthesis system handpiece Bone pin ultrasonic osteosynthesis system handpiece Bone pin ultrasonic osteosynthesis system handpiece Bone pin ultrasonic osteosynthesis system handpiece Bone pin ultrasonic osteosynthesis system handpiece Bone pin ultrasonic osteosynthesis system handpiece Bone pin ultrasonic osteosynthesis system handpiece Bone pin ultrasonic osteosynthesis system handpiece Bone pin ultrasonic osteosynthesis system handpiece Bone pin ultrasonic osteosynthesis system handpiece Bone pin ultrasonic osteosynthesis system handpiece Bone pin ultrasonic osteosynthesis system handpiece Bone pin ultrasonic osteosynthesis system handpiece

• Primary Device ID: 07613252495086
• NIH Device Record Key: 5c6888d5-d2fa-454a-bf33-14ca99848439
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SONICFUSION
• Version Model Number: 1910-2001
• Catalog Number: 1910-2001
• Company DUNS: 330211587
• Company Name: Stryker Trauma GmbH
• 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: true
• Serial Number: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613252495086 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091955

FDA Product Code

• HTY: PIN, FIXATION, SMOOTH

Sterilization

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

[07613252495086]

Moist Heat or Steam Sterilization

[07613252495086]

Moist Heat or Steam Sterilization

[07613252495086]

Moist Heat or Steam Sterilization

[07613252495086]

Moist Heat or Steam Sterilization

[07613252495086]

Moist Heat or Steam Sterilization

[07613252495086]

Moist Heat or Steam Sterilization

[07613252495086]

Moist Heat or Steam Sterilization

[07613252495086]

Moist Heat or Steam Sterilization

[07613252495086]

Moist Heat or Steam Sterilization

[07613252495086]

Moist Heat or Steam Sterilization

[07613252495086]

Moist Heat or Steam Sterilization

[07613252495086]

Moist Heat or Steam Sterilization

[07613252495086]

Moist Heat or Steam Sterilization

[07613252495086]

Moist Heat or Steam Sterilization

[07613252495086]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

On-Brand Devices [SONICFUSION]

• 07613327129649: Instrument Tray
• 07613327096071: TipTool
• 07613327096033: TipTool
• 07613327096019: Handpiece
• 07613327095470: Handpiece Tip
• 07613327095463: Handpiece Tip
• 07613327095418: Drill
• 07613327095371: Drill
• 07613252495116: Instrument Tray SonicPin
• 07613252495093: Foot Switch
• 07613252495086: Handpiece SonicPin
• 07613252495079: Ultrasonic Generator
• 07613252495161: Direct Depth Gauge SonicPin
• 07613252495154: Drill cannulated SonicPin (Pin26mm)
• 07613252495147: Drill SonicPin
• 07613252495123: Drill cannulated SonicPin
• 07613252212348: Drill SonicPin