16 MHz probe, 3mm with adapter cable 6588

GUDID 04260493310840

16 MHz probe Ø 3.0 mm (soft cable) with adapter cable for patient isolation

Compumedics Germany GmbH

Invasive vascular ultrasound system probe

• Primary Device ID: 04260493310840
• NIH Device Record Key: cd6df5d7-bc8b-447a-99ea-a4ca5176ab73
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 16 MHz probe, 3mm with adapter cable
• Version Model Number: 16 MHz_3S
• Catalog Number: 6588
• Company DUNS: 344791632
• Company Name: Compumedics Germany GmbH
• 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: false
• 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: +1 888 757 5351
• Email: info@dwl.de
• Phone: +1 888 757 5351
• Email: info@dwl.de
• Phone: +1 888 757 5351
• Email: info@dwl.de
• Phone: +1 888 757 5351
• Email: info@dwl.de
• Phone: +1 888 757 5351
• Email: info@dwl.de
• Phone: +1 888 757 5351
• Email: info@dwl.de
• Phone: +1 888 757 5351
• Email: info@dwl.de
• Phone: +1 888 757 5351
• Email: info@dwl.de
• Phone: +1 888 757 5351
• Email: info@dwl.de
• Phone: +1 888 757 5351
• Email: info@dwl.de
• Phone: +1 888 757 5351
• Email: info@dwl.de
• Phone: +1 888 757 5351
• Email: info@dwl.de
• Phone: +1 888 757 5351
• Email: info@dwl.de
• Phone: +1 888 757 5351
• Email: info@dwl.de
• Phone: +1 888 757 5351
• Email: info@dwl.de
• Phone: +1 888 757 5351
• Email: info@dwl.de
• Phone: +1 888 757 5351
• Email: info@dwl.de
• Phone: +1 888 757 5351
• Email: info@dwl.de
• Phone: +1 888 757 5351
• Email: info@dwl.de
• Phone: +1 888 757 5351
• Email: info@dwl.de
• Phone: +1 888 757 5351
• Email: info@dwl.de
• Phone: +1 888 757 5351
• Email: info@dwl.de
• Phone: +1 888 757 5351
• Email: info@dwl.de
• Phone: +1 888 757 5351
• Email: info@dwl.de
• Phone: +1 888 757 5351
• Email: info@dwl.de
• Phone: +1 888 757 5351
• Email: info@dwl.de
• Phone: +1 888 757 5351
• Email: info@dwl.de
• Phone: +1 888 757 5351
• Email: info@dwl.de

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260493310840 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051085

FDA Product Code

• ITX: Transducer, Ultrasonic, Diagnostic

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-12-16
• Device Publish Date: 2020-12-08

Devices Manufactured by Compumedics Germany GmbH

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• 04260493310987 - LAM Fixation Mandibula: 2020-12-17 LAM Set Mandibula WITHOUT probes, bilateral, screw topped
• 04260493311007 - LAM Fixation Neurosurgery: 2020-12-17 LAM Set Neurosurgery WITHOUT probes, bilateral, screw topped
• 04260493311014 - LAM Fixation Carotid surgery: 2020-12-17 LAM Set Carotid surgery WITHOUT probes, bilateral, screw topped
• 04260493311045 - Headband Fixation L/XL: 2020-12-17 Headband Set WITHOUT probes, size L/XL, bilateral
• 04260493311052 - Headband Fixation L/XL: 2020-12-17 Headband Set size L/XL, unilateral with 2 MHz probe, screw topped
• 04260493311069 - Headband Fixation L/XL: 2020-12-17 Headband Set size L/XL, unilateral with 2 MHz probe, click&stay