| Primary Device ID | 00850015518072 |
| NIH Device Record Key | 685391fa-df2b-41dd-9bbc-25ca31c752f3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NaviCam Stomach System |
| Version Model Number | Locator AKS-1 |
| Company DUNS | 024972857 |
| Company Name | ANX ROBOTICA CORP |
| 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 | false |
| OTC Over-The-Counter | false |
| Phone | 770-480-2911 |
| tim.thomas@anxrobotics.som |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850015518072 [Primary] |
| QKZ | Magnetically Maneuvered Capsule Endoscopy System |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-12-16 |
| Device Publish Date | 2020-12-08 |
| 00850015518287 - NaviCam Tether | 2023-01-13 Tether Accessory. The NaviCam Capsule and NaviCam Tether are disposable sterile products, which serve as an accessory to the Nav |
| 00850015518294 - NaviCam Xpress Stomach Capsule Endoscope System, NaviCam Xpress Stomach System | 2023-01-13 Controller. The NaviCam Xpress Stomach System is a endoscopic capsule imaging system intended to obtain images of the stomach. I |
| 00850015518072 - NaviCam Stomach System | 2020-12-16NaviCam Capsule Endoscope System with NaviCam Stomach Capsule; NaviCam Stomach System. |
| 00850015518072 - NaviCam Stomach System | 2020-12-16 NaviCam Capsule Endoscope System with NaviCam Stomach Capsule; NaviCam Stomach System. |
| 00850015518188 - NaviCam Capsule Endoscope System | 2020-12-16 DATA RECORDER. The NaviCam Capsule Endoscope System with NaviCam Stomach Capsule (“NaviCam Stomach System” in short), is a n |
| 00850015518195 - NaviCam Capsule Endoscope System | 2020-12-16 The NaviCam Capsule Endoscope System with NaviCam Stomach Capsule (“NaviCam Stomach System” in short), is a novel endoscopic |
| 00850015518201 - NaviCam Capsule Endoscope System | 2020-12-16 Controller. The NaviCam Capsule Endoscope System with NaviCam Stomach Capsule (“NaviCam Stomach System” in short), is a nove |
| 00850015518232 - IntraMarX 3D | 2020-12-16 |
| 00850015518126 - IntraMarX | 2020-07-16 The IntraMarX capsule can be used for the diagnosis of many GI conditions, including chronic constipation, colonic inertia, hypo |