Gems
Gems Straps Various Various Fits CT Hilight, Hispeed Advantage, CT 8800 AND CT 3 per Set
4manufacturers in China registered for this device type
71catalogue numbers in this listing
Who Else Makes It
Concentrated in Beijing (1), Shanghai (1), Tianjin (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GE Healthcare (China) Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| Carestream Health, Inc., Global R&D Center | Shanghai | Shanghai | Specification developer | 8 |
| GE Healthcare (Tianjin) Company Limited | Tianjin | Tianjin | Specification developer | 5 |
| Baxter Medical Systems (Suzhou) Co., Ltd. | Taicang | Jiangsu | Contract manufacturer | 4 |
Record
| Listed by | Tidi Products, LLC, United States |
|---|---|
| FDA product code | KXJ |
| Device type | Table, Radiologic |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1980 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-10-05 |
| Record revised | 2023-02-28 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date |
| Distribution end date | 2023-03-02 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 28634 | Withdrawn | |
| 20324 | Withdrawn | |
| 23800 | Withdrawn | |
| 31120 | Withdrawn | |
| 21515 | Withdrawn | |
| 28099 | Withdrawn | |
| 20578 | Withdrawn | |
| 30346 | Withdrawn | |
| 20979FF | Withdrawn | |
| 33171 | Withdrawn | |
| 30564 | Withdrawn | |
| 21784 | Withdrawn | |
| 28057 | Withdrawn | |
| 27440 | Withdrawn | |
| 20326 | Withdrawn | |
| 21428 | Withdrawn | |
| 21234 | Withdrawn | |
| 21235 | Withdrawn | |
| 20583 | Withdrawn | |
| 30416 | Withdrawn | |
| 20676 | Withdrawn | |
| 20603 | Withdrawn | |
| 20579 | Withdrawn | |
| 24450 | Withdrawn | |
| 32964 | Withdrawn | |
| 21512 | Withdrawn | |
| 30348 | Withdrawn | |
| 20601 | Withdrawn | |
| 22207 | Withdrawn | |
| 28060 | Withdrawn | |
| 21308 | Withdrawn | |
| 23802 | Withdrawn | |
| 20296 | Withdrawn | |
| 20810F | Withdrawn | |
| 21389 | Withdrawn | |
| 21785 | Withdrawn | |
| 20688 | Withdrawn | |
| 31904 | Withdrawn | |
| 20588 | Withdrawn | |
| 21198 | Withdrawn | |
| 28179 | Withdrawn | |
| 20518 | Withdrawn | |
| 20517 | Withdrawn | |
| 20977FF | Withdrawn | |
| 23480 | Withdrawn | |
| 20820F | Withdrawn | |
| 20272 | Withdrawn | |
| 20929F | Withdrawn | |
| 28023 | Withdrawn | |
| 21163 | Withdrawn | |
| 28058 | Withdrawn | |
| 21513 | Withdrawn | |
| 20602 | Withdrawn | |
| 21540 | Withdrawn | |
| 20589 | Withdrawn | |
| 21332 | Withdrawn | |
| 33177 | Withdrawn | |
| 25325 | Withdrawn | |
| 26952 | Withdrawn | |
| 20692F | Withdrawn | |
| 20048 | Withdrawn | |
| 20690 | Withdrawn | |
| 25932 | Withdrawn | |
| 20630 | Withdrawn | |
| 22633 | Withdrawn | |
| 20519 | Withdrawn | |
| 20705 | Withdrawn | |
| 20520 | Withdrawn | |
| 24947 | Withdrawn | |
| 20582 | Withdrawn | |
| 26940 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Tidi | Tidi Products, LLC | 1,329 |
| Table, Radiologic | Domico Med-Device, LLC | 351 |
| Hillrom™ | Baxter Medical Systems GmbH + Co. KG | 167 |
| Trumpf Medical | Baxter Medical Systems GmbH + Co. KG | 118 |
| Scancoat | Domico Med-Device, LLC | 82 |
| Pads | Baxter Medical Systems GmbH + Co. KG | 41 |
| Bone Foam | Tidi Products, LLC | 25 |
| TS 7500 | Baxter Medical Systems GmbH + Co. KG | 21 |
| Orthopedic Extension | Baxter Medical Systems GmbH + Co. KG | 19 |
| Bionix | Tidi Products, LLC | 16 |
| Control Units | Baxter Medical Systems GmbH + Co. KG | 11 |
| Head Sections | Baxter Medical Systems GmbH + Co. KG | 11 |
Showing 12 of 107. All products under Table, Radiologic
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.