Medistim Vascular TTFM probe PV100161

GUDID 07070554101068

Medistim ASA

Invasive vascular ultrasound system probe

• Primary Device ID: 07070554101068
• NIH Device Record Key: bcaaab1b-bd96-4d3b-8500-20f2904b5d69
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Medistim Vascular TTFM probe
• Version Model Number: PV100161
• Catalog Number: PV100161
• 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: true
• 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	07070554101068 [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

[07070554101068]

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

[07070554101068]

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

[07070554101068]

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

[07070554101068]

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

[07070554101068]

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

[07070554101068]

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

[07070554101068]

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

[07070554101068]

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

[07070554101068]

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

[07070554101068]

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

[07070554101068]

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

[07070554101068]

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

[07070554101068]

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

[07070554101068]

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

[07070554101068]

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

On-Brand Devices [Medistim Vascular TTFM probe]

• 07070554101181: PV100052
• 07070554101174: PV100051
• 07070554101167: PV100042
• 07070554101150: PV100041
• 07070554101143: PV100032
• 07070554101136: PV100031
• 07070554101129: PV100021
• 07070554101112: PV101011
• 07070554101082: PV100142
• 07070554101075: PV100162
• 07070554101068: PV100161
• 07070554101051: PV100122
• 07070554101044: PV100121
• 07070554101037: PV100102
• 07070554101020: PV100101
• 07070554100993: PV100141
• 07070554100986: PV100082
• 07070554100979: PV100081
• 07070554100962: PV100062
• 07070554100955: PV100061