Single-Use Needle Guide

GUDID 05704916000813

Sterile packed. Accepts needles 10-20 gauge; angle of insertion 30° to the image axis

Bk Medical ApS

Nonimplantable needle guide, single-use

• Primary Device ID: 05704916000813
• NIH Device Record Key: 2a9a10f0-647c-49c1-9ec1-cd066e6d51e1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Single-Use Needle Guide
• Version Model Number: UA1335
• 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: 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: 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: 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05704916000806 [Primary]
GS1	05704916000813 [Package]; Contains: 05704916000806; Package: [9 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083667

FDA Product Code

• ITX: Transducer, Ultrasonic, Diagnostic

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

On-Brand Devices [Single-Use Needle Guide ]

• 05704916001018: Sterile packed. Includes 1 needle guide palette and 9 different inserts for 10-20 gauge needles
• 05704916000998: Sterile packed. Includes 2 needle guide insert palettes (3-angle and free-angle respectively), e
• 05704916000875: Sterile packed. Includes: 4 free-angle in-plane inserts, 4 out-of-plane 4-channel inserts and 4
• 05704916000851: Sterile packed. Includes 2 needle guide insert palettes (3-angle and free-angle respectively), e
• 05704916000837: Sterile-packed. Includes: 3-angle insert for 10-20 gauge needles (9 pcs), free-angle insert for
• 05704916000813: Sterile packed. Accepts needles 10-20 gauge; angle of insertion 30° to the image axis