Primary Device ID | 05704916001346 |
NIH Device Record Key | ba2903c2-5abf-48fb-8084-1cff97030f51 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Water Standoff Collar |
Version Model Number | UA0671 |
Company DUNS | 310093901 |
Company Name | Bk Medical ApS |
Device Count | 1 |
DM Exempt | true |
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 | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | +4544528100 |
info@bkmedical.com | |
Phone | +4544528100 |
info@bkmedical.com | |
Phone | +4544528100 |
info@bkmedical.com | |
Phone | +4544528100 |
info@bkmedical.com | |
Phone | +4544528100 |
info@bkmedical.com | |
Phone | +4544528100 |
info@bkmedical.com | |
Phone | +4544528100 |
info@bkmedical.com | |
Phone | +4544528100 |
info@bkmedical.com | |
Phone | +4544528100 |
info@bkmedical.com | |
Phone | +4544528100 |
info@bkmedical.com | |
Phone | +4544528100 |
info@bkmedical.com | |
Phone | +4544528100 |
info@bkmedical.com | |
Phone | +4544528100 |
info@bkmedical.com | |
Phone | +4544528100 |
info@bkmedical.com | |
Phone | +4544528100 |
info@bkmedical.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 05704916001346 [Primary] |
ITX | Transducer, Ultrasonic, Diagnostic |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-05-08 |
Device Publish Date | 2025-04-30 |
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 | 2025-05-08Water Standoff Collar for 20R3 / 9052 Transducer |
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 |