N11C5s Transducer

GUDID 05704916000202

Intraoperative (neuro) imaging, Intraoperative imaging

Bk Medical ApS

Surgical ultrasound imaging transducer

• Primary Device ID: 05704916000202
• NIH Device Record Key: 4ba91dbc-5d31-4ec5-b1b1-21e18d8b1e17
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N11C5s Transducer
• Version Model Number: 9063
• Company DUNS: 310093901
• Company Name: Bk Medical ApS
• 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: 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

Customer Support Contacts

• Phone: +4544528100
• Email: info@bkultrasound.com
• Phone: +4544528100
• Email: info@bkultrasound.com
• Phone: +4544528100
• Email: info@bkultrasound.com
• Phone: +4544528100
• Email: info@bkultrasound.com
• Phone: +4544528100
• Email: info@bkultrasound.com
• Phone: +4544528100
• Email: info@bkultrasound.com
• Phone: +4544528100
• Email: info@bkultrasound.com
• Phone: +4544528100
• Email: info@bkultrasound.com
• Phone: +4544528100
• Email: info@bkultrasound.com
• Phone: +4544528100
• Email: info@bkultrasound.com
• Phone: +4544528100
• Email: info@bkultrasound.com
• Phone: +4544528100
• Email: info@bkultrasound.com
• Phone: +4544528100
• Email: info@bkultrasound.com
• Phone: +4544528100
• Email: info@bkultrasound.com
• Phone: +4544528100
• Email: info@bkultrasound.com
• Phone: +4544528100
• Email: info@bkultrasound.com
• Phone: +4544528100
• Email: info@bkultrasound.com
• Phone: +4544528100
• Email: support@bkmedical.com
• Phone: +4544528100
• Email: support@bkmedical.com
• Phone: +4544528100
• Email: support@bkmedical.com
• Phone: +4544528100
• Email: support@bkmedical.com
• Phone: +4544528100
• Email: support@bkmedical.com
• Phone: +4544528100
• Email: support@bkmedical.com
• Phone: +4544528100
• Email: support@bkmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05704916000202 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140428

FDA Product Code

• ITX: Transducer, Ultrasonic, Diagnostic

Sterilization

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

[05704916000202]

Peracetic Acid;Chlorine Dioxide;Hydrogen Peroxide

[05704916000202]

Peracetic Acid;Chlorine Dioxide;Hydrogen Peroxide

[05704916000202]

Peracetic Acid;Chlorine Dioxide;Hydrogen Peroxide

[05704916000202]

Peracetic Acid;Chlorine Dioxide;Hydrogen Peroxide

[05704916000202]

Peracetic Acid;Chlorine Dioxide;Hydrogen Peroxide

[05704916000202]

Peracetic Acid;Chlorine Dioxide;Hydrogen Peroxide

[05704916000202]

Peracetic Acid;Chlorine Dioxide;Hydrogen Peroxide

[05704916000202]

Peracetic Acid;Chlorine Dioxide;Hydrogen Peroxide

[05704916000202]

Peracetic Acid;Chlorine Dioxide;Hydrogen Peroxide

[05704916000202]

Peracetic Acid;Chlorine Dioxide;Hydrogen Peroxide

[05704916000202]

Peracetic Acid;Chlorine Dioxide;Hydrogen Peroxide

[05704916000202]

Peracetic Acid;Chlorine Dioxide;Hydrogen Peroxide

[05704916000202]

Peracetic Acid;Chlorine Dioxide;Hydrogen Peroxide

[05704916000202]

Peracetic Acid;Chlorine Dioxide;Hydrogen Peroxide

[05704916000202]

Peracetic Acid;Chlorine Dioxide;Hydrogen Peroxide

[05704916000202]

Peracetic Acid;Chlorine Dioxide;Hydrogen Peroxide

[05704916000202]

Peracetic Acid;Chlorine Dioxide;Hydrogen Peroxide

[05704916000202]

Peracetic Acid;Chlorine Dioxide;Hydrogen Peroxide

[05704916000202]

Peracetic Acid;Chlorine Dioxide;Hydrogen Peroxide

[05704916000202]

Peracetic Acid;Chlorine Dioxide;Hydrogen Peroxide

[05704916000202]

Peracetic Acid;Chlorine Dioxide;Hydrogen Peroxide

[05704916000202]

Peracetic Acid;Chlorine Dioxide;Hydrogen Peroxide

[05704916000202]

Peracetic Acid;Chlorine Dioxide;Hydrogen Peroxide

[05704916000202]

Peracetic Acid;Chlorine Dioxide;Hydrogen Peroxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-17

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• 05704916001131 - N20P6 Transducer: 2020-04-03 High resolution, mini footprint, Intraoperative (neuro) imaging
• 05704916001315 - I12C5 transducer: 2020-04-03 Peripheral vessel (vascular), Pediatric, Small organs (small parts), Musculoskeletal (conventional and superficial)
• 05704916001407 - Non-implantable, needle guide, reusable: 2019-12-23 Reusable Transperineal Needle Guide