N-Spot
Nipple Markers, 2.3mm non-metallic pellet, pinch-free material with larger adhesive free center
1manufacturer
16catalogue numbers in this listing
8recalls on this code
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 | Beekley 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 | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2019-07-22 |
| Record revised | 2024-09-04 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number |
| Distribution end date | 2024-08-29 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 690 | 94 | In distribution | |
| 653S | 6 | In distribution | |
| 790 | 94 | In distribution | |
| 653 | 110 | In distribution | |
| 632 | 110 | In distribution | |
| 790P | 94 | In distribution | |
| 690S | 6 | In distribution | |
| 790S | 6 | In distribution | |
| 790PS | 6 | In distribution | |
| 732S | 6 | In distribution | |
| 632S | 6 | In distribution | |
| 732 | 110 | In distribution | |
| 608 | 122 | Withdrawn | |
| 608S | 6 | Withdrawn | |
| 610S | 6 | Withdrawn | |
| 610 | 122 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Suremark | Jessop Precision Products Inc. | 18 |
| 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 |
| 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
Recalls
7 of these are Class II. Class II means a temporary or reversible health consequence. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2018-06-13 | Class II | Nonconforming Material/Component | There is a potential for imaging artifact to mimic calcifications on patient’s mammograms | 3,384,024 pieces in total. | 2018-11-13 |
| 2018-06-13 | Class II | Nonconforming Material/Component | There is a potential for imaging artifact to mimic calcifications on patient’s mammograms | 3,384,024 pieces in total. | 2018-11-13 |
| 2018-06-13 | Class II | Nonconforming Material/Component | There is a potential for imaging artifact to mimic calcifications on patient’s mammograms | 3,384,024 pieces in total. | 2018-11-13 |
| 2017-05-08 | Class III | Employee error | Mammography Skin Marker 0 -SPOT (REF 652) product was mis-labeled with A-SPOT (REF 651) labels | 104 boxes (58/box)= 6,032 total units | 2017-06-20 |
| 2012-07-09 | Class II | Unknown/Undetermined by firm | Digital Skin Mammography Marker separating from the backing of the spot material | 32,640 units | 2013-07-09 |
| 2012-07-09 | Class II | Unknown/Undetermined by firm | Digital Skin Mammography Marker separating from the backing of the spot material | 36,518 units | 2013-07-09 |
| 2012-07-09 | Class II | Unknown/Undetermined by firm | Digital Skin Mammography Marker separating from the backing of the spot material | 6420 units | 2013-07-09 |
| 2012-07-09 | Class II | Unknown/Undetermined by firm | Digital Skin Mammography Marker separating from the backing of the spot material | 267,332 units | 2013-07-09 |
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.