Scancoat
SCANCOAT®, KIT, CT POSITIONING. Includes: 105-SCB - SCANCOAT®, WEDGE, 3.75” x 9” x 8” (10810050242834), 106-SCB – SCANCOAT®, WEDGE, 6.63” x 6.63” x 12” (00810050242011), 113-SCB -…
SCANCOAT®, KIT, CT POSITIONING. Includes: 105-SCB – SCANCOAT®, WEDGE, 3.75” x 9” x 8” (10810050242834), 106-SCB → SCANCOAT®, WEDGE, 6.63” x 6.63” x 12” (00810050242011), 113-SCB – SCANCOAT®, WEDGE, 2.25” x 9.5” x 7.25” (10810050242780), 118-SCB – SCANCOAT®, WEDGE, 7” x 7” x 7” (00810050242073), 120-SCB → SCANCOAT®, WEDGE, 2.50” x 8” x 7” (00810050243681), 123-SCB → SCANCOAT®, WEDGE, 6.63” x 9” x 12” (00810050240833), 130-SCB – SCANCOAT®, WEDGE, 10″ x 10″ x 10″ (00810050244060), 136-SCB → SCANCOAT®, WEDGE, 2.25” x 8” x 10” (00810050243124), 138-SCB → SCANCOAT®, WEDGE, 3.75” x 8” x 10” (00810050240154), 140-SCB – SCANCOAT®, WEDGE, 6″ x 10″ x 10″ (00810050243629)
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 | Domico Med-Device, 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, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-09-24 |
| Record revised | 2023-02-22 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date, serial number |
| Sizes | Height 1 to 11 in; width 3 to 24 in; length 0.5 to 78.75 in; outer diameter 4.25 to 7 in |
| Distribution end date | 2023-02-17 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 9008A | In distribution | ||
| 126-SCB-00-001 | Height 6 in | In distribution | |
| 141-SCB | Height 9 in | In distribution | |
| 118-SCB | Height 7 in | In distribution | |
| 114-SCB | Height 2.00 in | In distribution | |
| 169-SCB | Height 3 in | In distribution | |
| 110-SCB | Height 3.00 in | 2 | In distribution |
| 4-SCB | In distribution | ||
| 9000 | Height 1.00 in | In distribution | |
| 100-SCB | Height 7.00 in | In distribution | |
| 428-SCB | In distribution | ||
| 9-SCB | In distribution | ||
| 127-SCB | In distribution | ||
| 99-SCB | In distribution | ||
| 107-SCB | Height 7.25 in | In distribution | |
| 204-SCB | In distribution | ||
| 152-SCB | Height 3 in | In distribution | |
| 116-SCB | Height 3 in | 2 | In distribution |
| 121-SCB | Height 3.13 in | In distribution | |
| 112-SCB | Height 1.5 in | In distribution | |
| 158-SCB | Height 3 in | 2 | In distribution |
| 19-SCB | In distribution | ||
| 140-SCB | Height 6 in | In distribution | |
| 194-SCB | Height 10 in | In distribution | |
| 14-SCB | In distribution | ||
| 201-SCB | Height 11 in | In distribution | |
| 191-SCB | Height 7 in | In distribution | |
| 111-SCB | Height 6.75 in | In distribution | |
| 106-SCB | Height 6.63 in | In distribution | |
| 153-SCB | Outer Diameter 4.25 in | In distribution | |
| 2-SCB | In distribution | ||
| 103-SCB | Height 3.00 in | In distribution | |
| 427-SCB | Height 7 in | In distribution | |
| 144-SCB | Height 7 in | In distribution | |
| 139-SCB | Height 7 in | In distribution | |
| 126-SCB-00-003 | Height 6 in | In distribution | |
| 133-SCB | In distribution | ||
| 126-SCB-00-002 | Height 6 in | In distribution | |
| 126-SCB-00-004 | Height 6 in | In distribution | |
| 113-SCB | Height 2.25 in | 2 | In distribution |
| 439-SCB | Height 10.37 in | In distribution | |
| 191-UF-SCB | Height 7 in | In distribution | |
| 401-SCB | Height 6 in | In distribution | |
| 145-SCB | Height 7 in | In distribution | |
| 193-SCB | Height 7 in | In distribution | |
| 151-UF-SCB | Height 4 in | In distribution | |
| 117-SCB | Height 2.5 in | 2 | In distribution |
| 131-SCB | Height 4 in | In distribution | |
| 9020F | In distribution | ||
| 3-SCB | In distribution | ||
| 122-SCB | Height 3.50 in | 2 | In distribution |
| 429-SCB | In distribution | ||
| 126-SCB | In distribution | ||
| 123-SCB | Height 6.63 in | In distribution | |
| 101-SCB | Height 7 in | In distribution | |
| 130-SCB | Height 10 in | In distribution | |
| 5-SCB | In distribution | ||
| 151-SCB | Height 4 in | In distribution | |
| 120-SCB | Height 2.50 in | In distribution | |
| 300-SCB | 2 | In distribution | |
| 17-SCB | In distribution | ||
| 105-SCB | Height 3.75 in | 2 | In distribution |
| 115-SCB | Height 5 in | In distribution | |
| 124-SCB | Height 6.63 in | In distribution | |
| 9001 | In distribution | ||
| 109-SCB | Height 7.25 in | In distribution | |
| 203-SCB | In distribution | ||
| 9008B | In distribution | ||
| 192-SCB | Height 5 in | In distribution | |
| 209-SCB | In distribution | ||
| 136-SCB | Height 2.25 in | In distribution | |
| 9015A | In distribution | ||
| 142-SCB | Height 3 in | Withdrawn | |
| 149-SCB | Outer Diameter 7 in | Withdrawn | |
| 1-SCB | Withdrawn | ||
| 119-SCB | Withdrawn | ||
| 128-SCB | Height 3 in | Withdrawn | |
| 159-SCB | Height 4 in | 2 | Withdrawn |
| 7-SCB | Withdrawn | ||
| 108-SCB | Height 5 in | Withdrawn | |
| 161-SCB | Height 4 in | Withdrawn | |
| 160-SCB | Height 3 in | 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 |
| Gems | Tidi Products, LLC | 71 |
| 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.