SonicFusion 0019102000

GUDID 07613327051292

Ultrasonic Generator

STRYKER CORPORATION

Ultrasonic osteosynthesis system generator

• Primary Device ID: 07613327051292
• NIH Device Record Key: 78443021-538d-4b69-934e-1bd4c8bda600
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SonicFusion
• Version Model Number: 0019102000
• Catalog Number: 0019102000
• Company DUNS: 187502109
• Company Name: STRYKER CORPORATION
• 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(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
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• Phone: +1(866)624-4422
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• Phone: +1(866)624-4422
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• Phone: +1(866)624-4422
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• Phone: +1(866)624-4422
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• Phone: +1(866)624-4422
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• Phone: +1(866)624-4422
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• Phone: +1(866)624-4422
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• Phone: +1(866)624-4422
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• Phone: +1(866)624-4422
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• Phone: +1(866)624-4422
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• Phone: +1(866)624-4422
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• Phone: +1(866)624-4422
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• Phone: +1(866)624-4422
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• Phone: +1(866)624-4422
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327051292 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091955

FDA Product Code

• HTY: PIN, FIXATION, SMOOTH

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: 2016-09-23

Devices Manufactured by STRYKER CORPORATION

• 07613327261882 - O.I.C. TITANIUM: 2025-03-07 DISTRACTOR
• 07613327625134 - Steri-Shield: 2025-03-06 8 SURGICAL HELMET
• 07613327625202 - Steri-Shield: 2025-03-06 8 BATTERY
• 07613327627039 - STERI-SHIELD: 2025-03-06 8 SURGICAL HELMET WITH LIGHT
• 07613327652154 - ProCuity: 2025-03-04 ProCuity L + IsoFlex
• 07613327652161 - ProCuity: 2025-03-04 ProCuity LE + IsoFlex
• 07613327652178 - ProCuity: 2025-03-04 ProCuity LE + ComfortGel
• 07613327652192 - ProCuity: 2025-03-04 ProCuity LEX + ComfortGel