Single-Use Dual Biopsy Guide

GUDID 05704916000790

Sterile packed. Bore diameter 1.6 mm; angle of insertion 0° and 19° to the long axis of the transducer

Bk Medical ApS

Nonimplantable needle guide, single-use

• Primary Device ID: 05704916000790
• NIH Device Record Key: fd87abdf-d6f5-44ff-9530-1e188687826a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Single-Use Dual Biopsy Guide
• Version Model Number: UA1329-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	05704916000783 [Primary]
GS1	05704916000790 [Package]; Contains: 05704916000783; 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: 5
• Public Version Date: 2019-10-07
• Device Publish Date: 2016-09-17

Devices Manufactured by Bk Medical ApS

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• 05704916001667 - Non-implantable needle guide, single-use: 2022-12-15 Disposable 18g Transperineal Needle Guide
• 05704916001698 - Non-implantable needle guide, single-use: 2022-12-15 Non-implantable needle guide, single-use
• 05704916001599 - Rob12C4: 2022-05-31 The Rob12C4 drop-in transducer enables unique access to complex organs and difficult-to-access anatomy during robotic-assisted p
• 05704916000240 - I13C3f Transducer: 2020-04-03 Intraoperative
• 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