RT-SPOT
- Primary DI
- 10815137022255
- Brand
- RT-SPOT
- Company
- Beekley Corporation
- Model
- 129S
- Catalog number
- 129S
- Device description
- CT Simulation Skin Markers
- Published
- 2024-08-29
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- true
Product Codes#
| Code | Name |
|---|---|
| JAC | System, X-Ray, Film Marking, Radiographic |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| JAC | System, X-Ray, Film Marking, Radiographic | Radiology | 1 |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00815137022289 | Primary | GS1 | 0 | |
| 10815137022255 | Unit of Use | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00815137022289 | 00815137022289 | 815137022289 | 0815137022289 |
| 10815137022255 | 10815137022255 |
GMDN Terms#
| Term | Definition |
|---|---|
| Radiological image marker, noninvasive, single-use | A non-powered, noninvasive device intended to be placed within the field of view of a radiological device [diagnostic (e.g., x-ray) and/or radiation therapy] to produce an identifying mark [typically for an anatomical location (e.g., mole, nipple, lesion), orientation (e.g., right or left limb), or patient identification] on films or digital images; it is not intended to be used during surgery. It is typically in the form of a small sticker or clip, and is positioned on or next to the patient, or on the film cassette or holder; it is not intended to be placed on teeth. It is made from materials compatible with the imaging system. This is a single-use device. |
Sterilization Methods#
| Method |
|---|
Regulatory Flags#
- DUNS number
- 001157841
- Device count
- 6
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- true
- Sterilization required before use
- false
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 00815137021077 | ColdSPOT | 500 | 2019-07-22 | |
| 00815137021084 | ColdSPOT | 502 | 2019-07-22 | |
| 00815137021060 | ColdSPOT | 505 | 2019-07-22 | |
| 00815137021978 | ColdSPOT | 500S | 2019-07-22 | |
| 00815137021985 | ColdSPOT | 502S | 2019-07-22 | |
| 00815137021992 | ColdSPOT | 505S | 2019-07-22 | |
| 00815137022043 | TenderTouch | 418 | 2020-07-31 | |
| 00815137022050 | TenderTouch | 418S | 2020-07-31 | |
| 00815137020056 | PointGuards | 115 | 2019-07-22 | |
| 00815137020254 | PointGuards | 315 | 2019-07-22 | |
| 00815137020261 | PointGuards | 316 | 2019-07-22 | |
| 00815137020278 | PointGuards | 318 | 2019-07-22 | |
| 00815137021398 | PointGuards | 115S | 2019-07-22 | |
| 00815137021541 | PointGuards | 215S | 2019-07-22 | |
| 00815137021619 | PointGuards | 315S | 2019-07-22 | |
| 00815137021626 | PointGuards | 316S | 2019-07-22 | |
| 00815137021633 | PointGuards | 318S | 2019-07-22 | |
| 00815137022326 | InkRight | 511 | 511 | 2024-10-23 |
| 00815137022333 | InkRight | 510S | 510S | 2024-10-23 |
| 00815137022340 | InkRight | 511S | 511S | 2024-10-23 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| D800ZBAC6305RAY0 | Printer Resin X-Ray Temporary (500g) | ZIRKONZAHN SRL | JAC | 2026-05-20 |
| 30815112021505 | E-Z-Mark | Bracco Diagnostics Inc. | JAC | 2026-01-09 |
| 00816589021219 | Fiducial Marker, Sterile | MONTERIS MEDICAL INC | JAC | 2025-02-07 |
| B201CGPAT0 | Clear Guide TP Access Tool | CLEAR GUIDE MEDICAL, INC. | JAC | 2025-01-10 |
| B201CGTPF0 | Clear Guide TP Access Frame | CLEAR GUIDE MEDICAL, INC. | JAC | 2025-01-10 |
| 00815137022265 | RT-SPOT | Beekley Corporation | JAC | 2024-08-29 |
| 00815137022272 | RT-SPOT | Beekley Corporation | JAC | 2024-08-29 |
| 00815137022289 | RT-SPOT | Beekley Corporation | JAC | 2024-08-29 |
| 00815137022296 | RT-SPOT | Beekley Corporation | JAC | 2024-08-29 |
| 00815137022302 | RT-SPOT | Beekley Corporation | JAC | 2024-08-29 |
| 00815137022258 | RT-SPOT | Beekley Corporation | JAC | 2024-08-29 |
| 10815137022262 | RT-SPOT | Beekley Corporation | JAC | 2024-08-29 |
| 10815137022279 | RT-SPOT | Beekley Corporation | JAC | 2024-08-29 |
| B971RTC120 | Suremark | Jessop Precision Products Inc. | JAC | 2024-02-01 |
| B971RTD12L0 | Suremark | Jessop Precision Products Inc. | JAC | 2024-02-01 |
| B971RTD12S0 | Suremark | Jessop Precision Products Inc. | JAC | 2024-02-01 |
| B971RTC121 | Suremark | Jessop Precision Products Inc. | JAC | 2024-02-01 |
| B971RTD12L1 | Suremark | Jessop Precision Products Inc. | JAC | 2024-02-01 |
| B971RTD12S1 | Suremark | Jessop Precision Products Inc. | JAC | 2024-02-01 |
| 03701313007942 | K-BALL | S.M.A.I.O | JAC | 2023-12-22 |
| 03613720287971 | UNiD™ Calibration Sphere | MEDTRONIC SOFAMOR DANEK, INC. | JAC | 2023-08-20 |
| B971RTC1000 | Suremark | Jessop Precision Products Inc. | JAC | 2023-01-16 |
| B971RTL100 | Suremark | Jessop Precision Products Inc. | JAC | 2023-01-16 |
| 00815137022166 | R-SPOT | Beekley Corporation | JAC | 2023-01-09 |
| 00815137022173 | L-SPOT | Beekley Corporation | JAC | 2023-01-09 |
| 10815137022163 | R-SPOT | Beekley Corporation | JAC | 2023-01-09 |
| 10815137022170 | L-SPOT | Beekley Corporation | JAC | 2023-01-09 |
| B201CGVM20 | Clear Guide VisiMARKER II | CLEAR GUIDE MEDICAL, INC. | JAC | 2022-10-04 |
| B201CGVM2NS0 | Clear Guide VisiMARKER II Non-Sterile | CLEAR GUIDE MEDICAL, INC. | JAC | 2022-10-04 |
| B201CGVMNS0 | Clear Guide VisiMARKER Non-Sterile | CLEAR GUIDE MEDICAL, INC. | JAC | 2022-10-04 |