Non-implantable, needle guide, reusable

GUDID 05704916001551

Reusable Biplane Biopsy Guide

Bk Medical ApS

Nonimplantable needle guide, reusable

• Primary Device ID: 05704916001551
• NIH Device Record Key: fe8c5c8c-42ba-4a20-83b8-2e4abad3e9d6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Non-implantable, needle guide, reusable
• Version Model Number: UA1326
• 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: 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@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

Operating and Storage Conditions

• Storage Environment Humidity: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between -25 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05704916001551 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173569

FDA Product Code

• ITX: Transducer, Ultrasonic, Diagnostic

Sterilization

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

[05704916001551]

Peracetic Acid;Hydrogen Peroxide;Chlorine Dioxide

[05704916001551]

Peracetic Acid;Hydrogen Peroxide;Chlorine Dioxide

[05704916001551]

Peracetic Acid;Hydrogen Peroxide;Chlorine Dioxide

[05704916001551]

Peracetic Acid;Hydrogen Peroxide;Chlorine Dioxide

[05704916001551]

Peracetic Acid;Hydrogen Peroxide;Chlorine Dioxide

[05704916001551]

Peracetic Acid;Hydrogen Peroxide;Chlorine Dioxide

[05704916001551]

Peracetic Acid;Hydrogen Peroxide;Chlorine Dioxide

[05704916001551]

Peracetic Acid;Hydrogen Peroxide;Chlorine Dioxide

[05704916001551]

Peracetic Acid;Hydrogen Peroxide;Chlorine Dioxide

[05704916001551]

Peracetic Acid;Hydrogen Peroxide;Chlorine Dioxide

[05704916001551]

Peracetic Acid;Hydrogen Peroxide;Chlorine Dioxide

[05704916001551]

Peracetic Acid;Hydrogen Peroxide;Chlorine Dioxide

[05704916001551]

Peracetic Acid;Hydrogen Peroxide;Chlorine Dioxide

[05704916001551]

Peracetic Acid;Hydrogen Peroxide;Chlorine Dioxide

[05704916001551]

Peracetic Acid;Hydrogen Peroxide;Chlorine Dioxide

[05704916001551]

Peracetic Acid;Hydrogen Peroxide;Chlorine Dioxide

[05704916001551]

Peracetic Acid;Hydrogen Peroxide;Chlorine Dioxide

[05704916001551]

Peracetic Acid;Hydrogen Peroxide;Chlorine Dioxide

[05704916001551]

Peracetic Acid;Hydrogen Peroxide;Chlorine Dioxide

[05704916001551]

Peracetic Acid;Hydrogen Peroxide;Chlorine Dioxide

[05704916001551]

Peracetic Acid;Hydrogen Peroxide;Chlorine Dioxide

[05704916001551]

Peracetic Acid;Hydrogen Peroxide;Chlorine Dioxide

[05704916001551]

Peracetic Acid;Hydrogen Peroxide;Chlorine Dioxide

[05704916001551]

Peracetic Acid;Hydrogen Peroxide;Chlorine Dioxide

[05704916001551]

Peracetic Acid;Hydrogen Peroxide;Chlorine Dioxide

[05704916001551]

Peracetic Acid;Hydrogen Peroxide;Chlorine Dioxide

[05704916001551]

Peracetic Acid;Hydrogen Peroxide;Chlorine Dioxide

[05704916001551]

Peracetic Acid;Hydrogen Peroxide;Chlorine Dioxide

[05704916001551]

Peracetic Acid;Hydrogen Peroxide;Chlorine Dioxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-12-23
• Device Publish Date: 2019-09-19

On-Brand Devices [Non-implantable, needle guide, reusable]

• 05704916001582: Reusable Needle Guide
• 05704916001575: Reusable Dual Biopsy Guide
• 05704916001568: Reusable Endfire Biopsy Guide
• 05704916001551: Reusable Biplane Biopsy Guide
• 05704916001520: Reusable Perineal Needle Guide
• 05704916001513: Reusable Needle Guide
• 05704916001445: Reusable Puncture Attachment
• 05704916001438: Reusable Needle Guide
• 05704916001421: Reusable Needle Guide
• 05704916001414: Reusable Needle Guide
• 05704916001407: Reusable Transperineal Needle Guide