Xact
BB marker, plastic, for Tomo/3D/CT, nipples and general marking, 2.0mm diameter,100/box
1manufacturer
14catalogue numbers in this listing
1510(k) clearance
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 | Solstice Corporation, United States |
|---|---|
| FDA product code | JAC |
| Device type | System, X-Ray, Film Marking, Radiographic |
| Device class | Class 1 |
| Regulation | 21 CFR 892.1640 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-02-26 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Latex | Labelled latex-free |
| Storage | Storage environment temperature -20 to 40 °C |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| M10LM | 320 | In distribution | |
| M23SC | 85 | In distribution | |
| M15S | 120 | In distribution | |
| M10R | 60 | In distribution | |
| M20SC | 100 | In distribution | |
| M15SC | 100 | In distribution | |
| M15RT | 80 | In distribution | |
| M10TT | 100 | In distribution | |
| M10TM | 120 | In distribution | |
| M20S | 120 | In distribution | |
| M15RM | 100 | In distribution | |
| M10AC | 80 | In distribution | |
| M10LT | 300 | In distribution | |
| M15R | 60 | 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 |
| 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 |
| CT-Markers | Nucletron B.V. | 7 |
| 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K925892 | 1993-05-18 |
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.