Non-implantable, needle guide, reusable

GUDID 05704916001445

Reusable Puncture Attachment

Bk Medical ApS

Nonimplantable needle guide, reusable

Primary Device ID	05704916001445
NIH Device Record Key	01595078-07dc-4999-be76-c6202798cbb8
Commercial Distribution Status	In Commercial Distribution
Brand Name	Non-implantable, needle guide, reusable
Version Model Number	UA1256
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	info@bkmedical.com
Phone	+4544528100
Email	info@bkmedical.com
Phone	+4544528100
Email	info@bkmedical.com
Phone	+4544528100
Email	info@bkmedical.com
Phone	+4544528100
Email	info@bkmedical.com
Phone	+4544528100
Email	info@bkmedical.com
Phone	+4544528100
Email	info@bkmedical.com
Phone	+4544528100
Email	info@bkmedical.com
Phone	+4544528100
Email	info@bkmedical.com
Phone	+4544528100
Email	info@bkmedical.com
Phone	+4544528100
Email	info@bkmedical.com
Phone	+4544528100
Email	info@bkmedical.com
Phone	+4544528100
Email	info@bkmedical.com
Phone	+4544528100
Email	info@bkmedical.com
Phone	+4544528100
Email	info@bkmedical.com
Phone	+4544528100
Email	info@bkmedical.com
Phone	+4544528100
Email	info@bkmedical.com
Phone	+4544528100
Email	info@bkmedical.com
Phone	+4544528100
Email	info@bkmedical.com
Phone	+4544528100
Email	info@bkmedical.com
Phone	+4544528100
Email	info@bkmedical.com
Phone	+4544528100
Email	info@bkmedical.com
Phone	+4544528100
Email	info@bkmedical.com
Phone	+4544528100
Email	info@bkmedical.com
Phone	+4544528100
Email	info@bkmedical.com
Phone	+4544528100
Email	info@bkmedical.com
Phone	+4544528100
Email	info@bkmedical.com
Phone	+4544528100
Email	info@bkmedical.com
Phone	+4544528100
Email	info@bkmedical.com
Phone	+4544528100
Email	info@bkmedical.com
Phone	+4544528100
Email	info@bkmedical.com
Phone	+4544528100
Email	info@bkmedical.com
Phone	+4544528100
Email	info@bkmedical.com
Phone	+4544528100
Email	info@bkmedical.com
Phone	+4544528100
Email	info@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
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	05704916001445 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K173569

FDA Product Code

ITX	Transducer, Ultrasonic, Diagnostic