CT-Markers
CT Marker 294 mm, Yellow
1manufacturer
7catalogue numbers in this listing
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangsu Rooe Medical Technology Co., Ltd. | Zhangjiagang | Jiangsu | Manufacturer | 31 |
Record
| Listed by | Nucletron B.V., Netherlands |
|---|---|
| FDA product code | JAC |
| Device type | System, X-Ray, Film Marking, Radiographic |
| Device class | Class 1 |
| Regulation | 21 CFR 892.1640 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-10-08 |
| Record revised | 2019-02-07 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Storage | Storage environment temperature 5 to 35 °C; Storage environment humidity 0 to 90 % RH |
| Packaging | Pack of 2, pack of 4, pack of 6, pack of 3 |
| Sizes | Length 200 to 294 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 189089P01-00 | Length 294.0 mm | 3 | In distribution |
| 189084P01-00 | 3 | In distribution | |
| 110614P01 | 3 | In distribution | |
| 110616P01-01 | 3 | In distribution | |
| 110617P01-01 | 3 | In distribution | |
| 110615P01-01 | 3 | In distribution | |
| 189086P01-00 | 3 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Suremark | Jessop Precision Products Inc. | 18 |
| N-Spot | Beekley Corporation | 16 |
| PortalMark | Jessop Precision Products Inc. | 14 |
| Xact | Solstice Corporation | 14 |
| TomoSPOT | Beekley Corporation | 10 |
| RT-Spot | Beekley Corporation | 8 |
| O-Spot | Beekley Corporation | 8 |
| MR-Spot | Beekley Corporation | 8 |
| CT-Spot | Beekley Corporation | 8 |
| S-Spot | Beekley Corporation | 8 |
| Scaneez | Jessop Precision Products Inc. | 7 |
| Visionline Kids | Jessop Precision Products Inc. | 6 |
Showing 12 of 68. All products under System, X-Ray, Film Marking, Radiographic
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.