Bone Foam
Bone Foam Positioning Aids - Leg Ether Foam F-806, F-830 Top Coat 12in x 26in x 6.84in 1 per Each
4manufacturers in China registered for this device type
25catalogue 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 | 2016-09-27 |
| 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 |
|---|---|---|
| 25192 | Withdrawn | |
| 30996 | Withdrawn | |
| 25185 | Withdrawn | |
| 26032 | Withdrawn | |
| 25201 | Withdrawn | |
| 25199 | Withdrawn | |
| 31202 | Withdrawn | |
| 31331 | Withdrawn | |
| 25188 | Withdrawn | |
| 25191 | Withdrawn | |
| 31384 | Withdrawn | |
| 32865 | Withdrawn | |
| 25186 | Withdrawn | |
| 31052 | Withdrawn | |
| 32613 | Withdrawn | |
| 25727 | Withdrawn | |
| 30979 | Withdrawn | |
| 31998 | Withdrawn | |
| 31466 | Withdrawn | |
| 25189 | Withdrawn | |
| 25184 | Withdrawn | |
| 25200 | Withdrawn | |
| 30584 | Withdrawn | |
| 30978 | Withdrawn | |
| 25187 | Withdrawn |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 |
| Gems | Tidi Products, LLC | 71 |
| Pads | Baxter Medical Systems GmbH + Co. KG | 41 |
| 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.