SD-3100
- Primary DI
- 08809832900258
- Brand
- SD-3100
- Company
- SHINYOUNG FOR M CO.,LTD.
- Model
- SD-3100_V1
- Published
- 2024-04-04
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- MR Safe
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| IYB | Tube Mount, X-Ray, Diagnostic |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| IYB | Tube Mount, X-Ray, Diagnostic | Radiology | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 08809832900258 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|
| 08809832900258 | 08809832900258 | 8809832900258 |
GMDN Terms
| Term | Definition |
|---|
| Radiological general body-part positioner | A device intended to facilitate adequate positioning and immobilization of a patient’s body part during diagnostic imaging procedures, image-guided surgical or interventional procedures, and/or radiation therapy procedures; it is not dedicated to a specific part of the body. The device is in the form of a frame, board, cushion, or preformed pad that may also be used to facilitate reproducible positioning for serial imaging studies or serial radiation therapy treatments. |
Regulatory Flags
- DUNS number
- 689883945
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- false
- 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
- false
- Sterilization required before use
- false
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| 08809832900227 | SS-2100 | SHINYOUNG FOR M CO.,LTD. | IYB | 2023-11-20 |
| 08809832900234 | SS-2100 | SHINYOUNG FOR M CO.,LTD. | IYB | 2023-11-20 |
| 05999116100269 | F100 TS99N TUBE MOUNT | CONTROL-X Medical Kereskedelmi és Szolgáltató Zártkörűen Működő Részvénytársaság | IYB | 2023-08-15 |
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| B884S10000110R0 | Paxis 100 Auto | Pausch, L.L.C. | IYB | 2023-05-12 |
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| B884S10000100R0 | Paxis 100 | Pausch, L.L.C. | IYB | 2022-12-06 |
| 00195278569745 | NA | Hangwei GE Medical Systems Co., Ltd. | IYB | 2022-07-21 |
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| 00860001123487 | Micro C Medical Imaging System, Weight Bearing Foot and Ankle System | Oxos Medical, Inc. | IYB | 2022-06-13 |
| 00858340006110 | Del Medical/Universal | Del Medical, Inc. | IYB | 2022-04-15 |
| 00858340006264 | Del Medical/Universal | Del Medical, Inc. | IYB | 2022-04-15 |
| 00858340006271 | Del Medical/Universal | Del Medical, Inc. | IYB | 2022-04-15 |
| 00858340006288 | Del Medical/Universal | Del Medical, Inc. | IYB | 2022-04-15 |