| Primary Device ID | 05704916000615 |
| NIH Device Record Key | 2c4744fd-2385-4162-a4a9-0b3ac60d8025 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Rigid Laparoscopic Transducer |
| Version Model Number | 8836 |
| 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 | true |
| 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 |
| Phone | +4544528100 |
| info@bkultrasound.com | |
| Phone | +4544528100 |
| info@bkultrasound.com | |
| Phone | +4544528100 |
| info@bkultrasound.com | |
| Phone | +4544528100 |
| info@bkultrasound.com | |
| Phone | +4544528100 |
| info@bkultrasound.com | |
| Phone | +4544528100 |
| info@bkultrasound.com | |
| Phone | +4544528100 |
| info@bkultrasound.com | |
| Phone | +4544528100 |
| info@bkultrasound.com | |
| Phone | +4544528100 |
| info@bkultrasound.com | |
| Phone | +4544528100 |
| info@bkultrasound.com | |
| Phone | +4544528100 |
| info@bkultrasound.com | |
| Phone | +4544528100 |
| info@bkultrasound.com | |
| Phone | +4544528100 |
| info@bkultrasound.com | |
| Phone | +4544528100 |
| info@bkultrasound.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 | |
| Phone | +4544528100 |
| info@bkmedical.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05704916000615 [Primary] |
| ITX | Transducer, Ultrasonic, Diagnostic |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[05704916000615]
Peracetic Acid;Hydrogen Peroxide;Chlorine Dioxide
[05704916000615]
Peracetic Acid;Hydrogen Peroxide;Chlorine Dioxide
[05704916000615]
Peracetic Acid;Hydrogen Peroxide;Chlorine Dioxide
[05704916000615]
Peracetic Acid;Hydrogen Peroxide;Chlorine Dioxide
[05704916000615]
Peracetic Acid;Hydrogen Peroxide;Chlorine Dioxide
[05704916000615]
Peracetic Acid;Hydrogen Peroxide;Chlorine Dioxide
[05704916000615]
Peracetic Acid;Hydrogen Peroxide;Chlorine Dioxide
[05704916000615]
Peracetic Acid;Hydrogen Peroxide;Chlorine Dioxide
[05704916000615]
Peracetic Acid;Hydrogen Peroxide;Chlorine Dioxide
[05704916000615]
Peracetic Acid;Hydrogen Peroxide;Chlorine Dioxide
[05704916000615]
Peracetic Acid;Hydrogen Peroxide;Chlorine Dioxide
[05704916000615]
Peracetic Acid;Hydrogen Peroxide;Chlorine Dioxide
[05704916000615]
Peracetic Acid;Hydrogen Peroxide;Chlorine Dioxide
[05704916000615]
Peracetic Acid;Hydrogen Peroxide;Chlorine Dioxide
[05704916000615]
Peracetic Acid;Hydrogen Peroxide;Chlorine Dioxide
[05704916000615]
Peracetic Acid;Hydrogen Peroxide;Chlorine Dioxide
[05704916000615]
Peracetic Acid;Hydrogen Peroxide;Chlorine Dioxide
[05704916000615]
Peracetic Acid;Hydrogen Peroxide;Chlorine Dioxide
[05704916000615]
Peracetic Acid;Hydrogen Peroxide;Chlorine Dioxide
[05704916000615]
Peracetic Acid;Hydrogen Peroxide;Chlorine Dioxide
[05704916000615]
Peracetic Acid;Hydrogen Peroxide;Chlorine Dioxide
[05704916000615]
Peracetic Acid;Hydrogen Peroxide;Chlorine Dioxide
[05704916000615]
Peracetic Acid;Hydrogen Peroxide;Chlorine Dioxide
[05704916000615]
Peracetic Acid;Hydrogen Peroxide;Chlorine Dioxide
[05704916000615]
Peracetic Acid;Hydrogen Peroxide;Chlorine Dioxide
[05704916000615]
Peracetic Acid;Hydrogen Peroxide;Chlorine Dioxide
[05704916000615]
Peracetic Acid;Hydrogen Peroxide;Chlorine Dioxide
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-17 |
| 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 |