Medistim QuickFIT TTFM probe PS100072

GUDID 07070554100856

Medistim ASA

Invasive vascular ultrasound system probe

• Primary Device ID: 07070554100856
• NIH Device Record Key: fe37391d-de19-47fb-9a7f-4f004a81bf06
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Medistim QuickFIT TTFM probe
• Version Model Number: PS100072
• Catalog Number: PS100072
• 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	07070554100856 [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

[07070554100856]

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

[07070554100856]

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

[07070554100856]

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

[07070554100856]

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

[07070554100856]

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

[07070554100856]

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

[07070554100856]

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

[07070554100856]

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

[07070554100856]

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

[07070554100856]

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

[07070554100856]

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

[07070554100856]

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

[07070554100856]

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

[07070554100856]

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

[07070554100856]

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

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 QuickFIT TTFM probe]

• 07070554101006: PS101011
• 07070554100856: PS100072
• 07070554100849: PS101012
• 07070554100832: PS100052
• 07070554100825: PS100042
• 07070554100818: PS100032
• 07070554100801: PS100022
• 07070554100764: PQ101011
• 07070554100757: PQ101012
• 07070554100733: PQ100051
• 07070554100726: PQ100041
• 07070554100719: PQ100031
• 07070554100092: PQ100052
• 07070554100085: PQ100042
• 07070554100078: PQ100032
• 07070554100061: PQ100022