E13C2 Transducer

GUDID 05704916000417

Rectal/vaginal ultrasound imaging transducer

Primary Device ID	05704916000417
NIH Device Record Key	3df98859-7610-4681-9949-4057548f0241
Commercial Distribution Status	In Commercial Distribution
Brand Name	E13C2 Transducer
Version Model Number	9029
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	false
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	05704916000417 [Primary]

ITX	Transducer, Ultrasonic, Diagnostic

Steralize Prior To Use	false
Device Is Sterile	false

05704916000288 - Foot Switch	2025-05-15 USB Foot Switch for bk3000, bk5000, bkActiv
05704916000318 - Wireless Remote Control	2025-05-15 Wireless Remote Control for bk3000 and bk5000
05704916001612 - Wireless Remote Control	2025-05-15 Wireless Remote Control for bkActiv
05704916000974 - Disposable Needle Guide	2025-05-08 Disposable needle guide for 5C1e (9085)
05704916001346 - Water Standoff Collar	2025-05-08 Water Standoff Collar for 20R3 / 9052 Transducer
05704916001353 - Rectosigmoidoscope with Obturator	2025-05-08 Rectosigmoidoscope with obturator, compatible with Welch Allyn Light Source for 20R3 / 9052
05704916001360 - Rectosigmoidoscope with Obturator	2025-05-08 Rectosigmoidoscope with obturator, compatible with Storz Light Source for 20R3 / 9052
05704916001537 - Dummy Channel Bracket	2025-05-08 Dummy Channel Bracket for 8808e, 8818