Single-Use Biplane Biopsy Guide

GUDID 05704916000738

Sterile packed. Bore diameter 1.6 mm; angle of insertion 19° to the long axis of the transducer

Bk Medical ApS

Nonimplantable needle guide, single-use

• Primary Device ID: 05704916000738
• NIH Device Record Key: cf08ca74-f7b9-4df0-8e9a-17867933490d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Single-Use Biplane Biopsy Guide
• Version Model Number: UA1322-S
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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: 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
• 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
• 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
• 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
• 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
• 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	05704916000721 [Primary]
GS1	05704916000738 [Package]; Contains: 05704916000721; Package: [18 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081323

FDA Product Code

• FCG: Biopsy Needle

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-10-07
• Device Publish Date: 2016-09-17

On-Brand Devices [Single-Use Biplane Biopsy Guide ]

• 05704916000752: Sterile packed. Bore diameter 2.1 mm; angle of insertion 19° to the long axis of the transducer
• 05704916000738: Sterile packed. Bore diameter 1.6 mm; angle of insertion 19° to the long axis of the transducer