SonoSurg MS Sheath N1807530

GUDID 04953170183058

OLYMPUS MEDICAL SYSTEMS CORP.

Soft-tissue ultrasonic surgical system handpiece, reusable Soft-tissue ultrasonic surgical system handpiece, reusable Soft-tissue ultrasonic surgical system handpiece, reusable Soft-tissue ultrasonic surgical system handpiece, reusable Soft-tissue ultrasonic surgical system handpiece, reusable Soft-tissue ultrasonic surgical system handpiece, reusable Soft-tissue ultrasonic surgical system handpiece, reusable Soft-tissue ultrasonic surgical system handpiece, reusable Soft-tissue ultrasonic surgical system handpiece, reusable Soft-tissue ultrasonic surgical system handpiece, reusable Soft-tissue ultrasonic surgical system handpiece, reusable Soft-tissue ultrasonic surgical system handpiece, reusable Soft-tissue ultrasonic surgical system handpiece, reusable Soft-tissue ultrasonic surgical system handpiece, reusable Soft-tissue ultrasonic surgical system handpiece, reusable Soft-tissue ultrasonic surgical system handpiece, reusable Soft-tissue ultrasonic surgical system handpiece, reusable Soft-tissue ultrasonic surgical system handpiece, reusable Soft-tissue ultrasonic surgical system handpiece, reusable Soft-tissue ultrasonic surgical system handpiece, reusable Soft-tissue ultrasonic surgical system handpiece, reusable Soft-tissue ultrasonic surgical system handpiece, reusable Soft-tissue ultrasonic surgical system handpiece, reusable Soft-tissue ultrasonic surgical system handpiece, reusable Soft-tissue ultrasonic surgical system handpiece, reusable Soft-tissue ultrasonic surgical system handpiece, reusable Soft-tissue ultrasonic surgical system handpiece, reusable Soft-tissue ultrasonic surgical system handpiece, reusable Soft-tissue ultrasonic surgical system handpiece, reusable Soft-tissue ultrasonic surgical system handpiece, reusable Soft-tissue ultrasonic surgical system handpiece, reusable Soft-tissue ultrasonic surgical system handpiece, reusable Soft-tissue ultrasonic surgical system handpiece, reusable Soft-tissue ultrasonic surgical system handpiece, reusable

• Primary Device ID: 04953170183058
• NIH Device Record Key: 45e5322c-d8cd-4194-be2f-42794873d317
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SonoSurg MS Sheath
• Version Model Number: T3420
• Catalog Number: N1807530
• 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: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04953170183058 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041566

FDA Product Code

• LFL: Instrument, Ultrasonic Surgical

Sterilization

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

[04953170183058]

Moist Heat or Steam Sterilization

[04953170183058]

Moist Heat or Steam Sterilization

[04953170183058]

Moist Heat or Steam Sterilization

[04953170183058]

Moist Heat or Steam Sterilization

[04953170183058]

Moist Heat or Steam Sterilization

[04953170183058]

Moist Heat or Steam Sterilization

[04953170183058]

Moist Heat or Steam Sterilization

[04953170183058]

Moist Heat or Steam Sterilization

[04953170183058]

Moist Heat or Steam Sterilization

[04953170183058]

Moist Heat or Steam Sterilization

[04953170183058]

Moist Heat or Steam Sterilization

[04953170183058]

Moist Heat or Steam Sterilization

[04953170183058]

Moist Heat or Steam Sterilization

[04953170183058]

Moist Heat or Steam Sterilization

[04953170183058]

Moist Heat or Steam Sterilization

[04953170183058]

Moist Heat or Steam Sterilization

[04953170183058]

Moist Heat or Steam Sterilization

[04953170183058]

Moist Heat or Steam Sterilization

[04953170183058]

Moist Heat or Steam Sterilization

[04953170183058]

Moist Heat or Steam Sterilization

[04953170183058]

Moist Heat or Steam Sterilization

[04953170183058]

Moist Heat or Steam Sterilization

[04953170183058]

Moist Heat or Steam Sterilization

[04953170183058]

Moist Heat or Steam Sterilization

[04953170183058]

Moist Heat or Steam Sterilization

[04953170183058]

Moist Heat or Steam Sterilization

[04953170183058]

Moist Heat or Steam Sterilization

[04953170183058]

Moist Heat or Steam Sterilization

[04953170183058]

Moist Heat or Steam Sterilization

[04953170183058]

Moist Heat or Steam Sterilization

[04953170183058]

Moist Heat or Steam Sterilization

[04953170183058]

Moist Heat or Steam Sterilization

[04953170183058]

Moist Heat or Steam Sterilization

[04953170183058]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-21
• Device Publish Date: 2023-06-13

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• 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