E14C4t Transducer

GUDID 05704916000066

Transrectal, Transvaginal

Bk Medical ApS

Rectal/vaginal ultrasound imaging transducer
Primary Device ID05704916000066
NIH Device Record Key46e69785-d96c-46f6-b9a0-6b6781b3051e
Commercial Distribution StatusIn Commercial Distribution
Brand NameE14C4t Transducer
Version Model Number9018
Company DUNS310093901
Company NameBk Medical ApS
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+4544528100
Emailinfo@bkultrasound.com
Phone+4544528100
Emailinfo@bkultrasound.com
Phone+4544528100
Emailinfo@bkultrasound.com
Phone+4544528100
Emailinfo@bkultrasound.com
Phone+4544528100
Emailinfo@bkultrasound.com
Phone+4544528100
Emailinfo@bkultrasound.com
Phone+4544528100
Emailinfo@bkultrasound.com
Phone+4544528100
Emailinfo@bkultrasound.com
Phone+4544528100
Emailinfo@bkultrasound.com
Phone+4544528100
Emailinfo@bkultrasound.com
Phone+4544528100
Emailinfo@bkultrasound.com
Phone+4544528100
Emailinfo@bkultrasound.com
Phone+4544528100
Emailinfo@bkultrasound.com
Phone+4544528100
Emailinfo@bkultrasound.com
Phone+4544528100
Emailinfo@bkultrasound.com
Phone+4544528100
Emailinfo@bkultrasound.com
Phone+4544528100
Emailinfo@bkultrasound.com
Phone+4544528100
Emailinfo@bkmedical.com
Phone+4544528100
Emailinfo@bkmedical.com
Phone+4544528100
Emailinfo@bkmedical.com
Phone+4544528100
Emailinfo@bkmedical.com
Phone+4544528100
Emailinfo@bkmedical.com
Phone+4544528100
Emailinfo@bkmedical.com
Phone+4544528100
Emailinfo@bkmedical.com
Phone+4544528100
Emailinfo@bkmedical.com
Phone+4544528100
Emailinfo@bkmedical.com
Phone+4544528100
Emailinfo@bkmedical.com
Phone+4544528100
Emailinfo@bkmedical.com
Phone+4544528100
Emailinfo@bkmedical.com
Phone+4544528100
Emailinfo@bkmedical.com
Phone+4544528100
Emailinfo@bkmedical.com
Phone+4544528100
Emailinfo@bkmedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS105704916000066 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ITXTransducer, Ultrasonic, Diagnostic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-10-11
Device Publish Date2016-09-17

Devices Manufactured by Bk Medical ApS

05704916000288 - Foot Switch2025-05-15 USB Foot Switch for bk3000, bk5000, bkActiv
05704916000318 - Wireless Remote Control2025-05-15 Wireless Remote Control for bk3000 and bk5000
05704916001612 - Wireless Remote Control2025-05-15 Wireless Remote Control for bkActiv
05704916000974 - Disposable Needle Guide2025-05-08 Disposable needle guide for 5C1e (9085)
05704916001346 - Water Standoff Collar2025-05-08 Water Standoff Collar for 20R3 / 9052 Transducer
05704916001353 - Rectosigmoidoscope with Obturator2025-05-08 Rectosigmoidoscope with obturator, compatible with Welch Allyn Light Source for 20R3 / 9052
05704916001360 - Rectosigmoidoscope with Obturator2025-05-08 Rectosigmoidoscope with obturator, compatible with Storz Light Source for 20R3 / 9052
05704916001537 - Dummy Channel Bracket2025-05-08 Dummy Channel Bracket for 8808e, 8818

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.