| Primary Device ID | 00810164590039 |
| NIH Device Record Key | e17f8555-c121-4d57-b136-53ef3b908447 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NaviCam SB Capsule/Tether |
| Version Model Number | ES-US-3001 |
| Catalog Number | ES-US-3001 |
| Company DUNS | 024972857 |
| Company Name | ANX ROBOTICA CORP |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| 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 | 855-777-0020 |
| info@anxrobotics.com | |
| Phone | 855-777-0020 |
| info@anxrobotics.com | |
| Phone | 855-777-0020 |
| info@anxrobotics.com | |
| Phone | 855-777-0020 |
| info@anxrobotics.com | |
| Phone | 855-777-0020 |
| info@anxrobotics.com | |
| Phone | 855-777-0020 |
| info@anxrobotics.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810164590039 [Primary] |
| NEZ | System, Imaging, Gastrointestinal, Wireless, Capsule |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-02-17 |
| Device Publish Date | 2026-02-09 |
| 00810164590008 - NaviCam SB Capsule | 2026-02-17 NaviCam SB Capsule is a gastrointestinal capsule endoscope used with the NaviCam SB Capsule Endoscope System to visualize the sm |
| 00810164590039 - NaviCam SB Capsule/Tether | 2026-02-17The NaviCam Capsule/Tether is a NaviCam SB capsule attached to a Tether to allow the physician to view the esophagus before releasing the NaviCam SB capsule into the stomach for a routing examination of the small bowel. |
| 00810164590039 - NaviCam SB Capsule/Tether | 2026-02-17 The NaviCam Capsule/Tether is a NaviCam SB capsule attached to a Tether to allow the physician to view the esophagus before rele |
| 00810164590633 - MotiliCap GI Monitoring System Data Recorder | 2026-02-17 The MotiliCap Data Recorder is used with the MotiliCap GI Monitoring System to receive and store transmitted data from the Motil |
| 00810164590640 - MotiliCap GI Monitoring System Software (MotiliScan) | 2026-02-17 The MotilCap Software (MotiliScan) is used with the MotiliCap GI monitoring system to record and analysis GI tract transit times |
| 00810164590657 - MotiliCap GI Monitoring System Capsule | 2026-02-17 The MotiliCap capsule is used with the MotiliCap GI Monitoring System which monitors the GI tract for temperature, pressure, and |
| 00810164590718 - NaviCam XS Capsule | 2026-02-17 The NaviCam SB XS Capsule is used with the NaviCam SB Capsule Endoscope System to visualize the small bowel. |
| 00810164590732 - NaviCam XS Capsule/Tether | 2026-02-17 The NaviCam XS Capsule/Tether is the NaviCam XS capsule with a Tether attached to allow the physicians to examine the esophagus |
| 00810164590817 - MotiliCap GI Monitoring System Mobile Phone/App | 2026-02-17 The MotiliCap Phone is used with the MotiliCap GI Monitoring System for the patient to record specified events during the proced |