Medistim Vascular TTFM probe PV100062

GUDID 07070554100962

Medistim ASA

Invasive vascular ultrasound system probe Invasive vascular ultrasound system probe Invasive vascular ultrasound system probe Invasive vascular ultrasound system probe Invasive vascular ultrasound system probe Invasive vascular ultrasound system probe Invasive vascular ultrasound system probe Invasive vascular ultrasound system probe Invasive vascular ultrasound system probe Invasive vascular ultrasound system probe Invasive vascular ultrasound system probe Invasive vascular ultrasound system probe Invasive vascular ultrasound system probe Invasive vascular ultrasound system probe Invasive vascular ultrasound system probe

• Primary Device ID: 07070554100962
• NIH Device Record Key: 3eb64b6a-d364-42f0-9b9a-44af64178c80
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Medistim Vascular TTFM probe
• Version Model Number: PV100062
• Catalog Number: PV100062
• Company DUNS: 519521751
• Company Name: Medistim ASA
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07070554100962 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K992305

FDA Product Code

• ITX: Transducer, Ultrasonic, Diagnostic

Sterilization

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

[07070554100962]

Moist Heat or Steam Sterilization;Liquid Chemical;Hydrogen Peroxide;Ethylene Oxide

[07070554100962]

Moist Heat or Steam Sterilization;Liquid Chemical;Hydrogen Peroxide;Ethylene Oxide

[07070554100962]

Moist Heat or Steam Sterilization;Liquid Chemical;Hydrogen Peroxide;Ethylene Oxide

[07070554100962]

Moist Heat or Steam Sterilization;Liquid Chemical;Hydrogen Peroxide;Ethylene Oxide

[07070554100962]

Moist Heat or Steam Sterilization;Liquid Chemical;Hydrogen Peroxide;Ethylene Oxide

[07070554100962]

Moist Heat or Steam Sterilization;Liquid Chemical;Hydrogen Peroxide;Ethylene Oxide

[07070554100962]

Moist Heat or Steam Sterilization;Liquid Chemical;Hydrogen Peroxide;Ethylene Oxide

[07070554100962]

Moist Heat or Steam Sterilization;Liquid Chemical;Hydrogen Peroxide;Ethylene Oxide

[07070554100962]

Moist Heat or Steam Sterilization;Liquid Chemical;Hydrogen Peroxide;Ethylene Oxide

[07070554100962]

Moist Heat or Steam Sterilization;Liquid Chemical;Hydrogen Peroxide;Ethylene Oxide

[07070554100962]

Moist Heat or Steam Sterilization;Liquid Chemical;Hydrogen Peroxide;Ethylene Oxide

[07070554100962]

Moist Heat or Steam Sterilization;Liquid Chemical;Hydrogen Peroxide;Ethylene Oxide

[07070554100962]

Moist Heat or Steam Sterilization;Liquid Chemical;Hydrogen Peroxide;Ethylene Oxide

[07070554100962]

Moist Heat or Steam Sterilization;Liquid Chemical;Hydrogen Peroxide;Ethylene Oxide

[07070554100962]

Moist Heat or Steam Sterilization;Liquid Chemical;Hydrogen Peroxide;Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-11-20
• Device Publish Date: 2016-09-15

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• 07070554100962: PV100062
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