PillCam
SB 2-EX capsule, 10-pack
1manufacturer
9catalogue numbers in this listing
Who Else Makes It
Registered in Hubei. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Ankon Technologies Co., Ltd. | Wuhan | Hubei | Contract manufacturer | 2 |
Record
| Listed by | Covidien LP, United States |
|---|---|
| FDA product code | NEZ |
| Device type | System, Imaging, Gastrointestinal, Wireless, Capsule |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1300 |
| Record published | 2017-01-31 |
| Record revised | 2025-06-24 (version 10) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, serial number |
| Storage | Handling environment temperature 20 to 40 °C; Storage environment temperature 0 to 25 °C |
| Distribution end date | 2021-03-31 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| FGS-0179 | Withdrawn | ||
| FGS-0418 | Withdrawn | ||
| FGS-0495 | 5 | Withdrawn | |
| FGS-0320 | Withdrawn | ||
| FGS-0419 | 5 | Withdrawn | |
| FGS-0200 | 10 | Withdrawn | |
| FGS-0143 | Withdrawn | ||
| FGS-0420 | 10 | Withdrawn | |
| FGS-0230 | 5 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Pillcam | Given Imaging Ltd. | 65 |
| Rapid | Given Imaging Ltd. | 21 |
| MiroCam Capsule Endoscope System | IntroMedic Co., Ltd. | 15 |
| NaviCam Small Bowel Capsule Endoscopy System | Ankon Technologies Co., Ltd. | 5 |
| System, Imaging, Gastrointestinal, Wireless, Capsule | Given Imaging Ltd. | 3 |
| PillCam Genius | Given Imaging Ltd. | 3 |
| AdvanCE | Us Endoscopy | 2 |
| MiroCam Capusle Endoscope System | IntroMedic Co., Ltd. | 2 |
| CapsoCam Plus | CapsoVision, Inc. | 2 |
| CapsoRetrieve | CapsoVision, Inc. | 2 |
| CapsoView | CapsoVision, Inc. | 1 |
| NaviCam Data Recorder | ANX Robotica Corp. | 1 |
Showing 12 of 44. All products under System, Imaging, Gastrointestinal, Wireless, Capsule
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.