OSUNG MND
- Primary DI
- 08800075626332
- Brand
- OSUNG MND
- Company
- OSUNG MND Co., Ltd.
- Model
- SBA18T1
- Device description
- A non-sterile, hand-held manual dental instrument consisting of a barrel (cylinder) with plunger intended to be used to inject impression material into an impression tray or directly into a patient's mouth. This is a reusable device.
- Published
- 2024-02-23
- 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
- false
Product Codes
| Code | Name |
|---|
| EJI | Syringe, Cartridge |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| EJI | Syringe, Cartridge | Dental | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 08800075626332 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|
| 08800075626332 | 08800075626332 | 8800075626332 |
GMDN Terms
| Term | Definition |
|---|
| Dental impression material syringe, reusable | A non-sterile hand-held manual dental instrument designed to inject impression material into an impression tray or directly into a patient's mouth. This is a reusable device. |
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags
- DUNS number
- 688207479
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- true
- Manufacturing date on label
- true
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- true
Other Devices From This Company
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|
| 00840326422663 | Astek | Young Innovations, Inc. | EJI | 2025-05-27 |
| 00840326423684 | Astek | Young Innovations, Inc. | EJI | 2025-05-27 |
| 00840326423721 | Astek | Young Innovations, Inc. | EJI | 2025-05-27 |
| 05713513001185 | ASPIJECT Active Compact | Rønvig Dental Manufacturing A/S | EJI | 2025-02-27 |
| 05060212057518 | Dental Syringe 85mm, for 2.2ml vial | DTR MEDICAL LIMITED | EJI | 2024-10-11 |
| 05060212057525 | Dental Syringe Long 115mm, for 2.2ml vial | DTR MEDICAL LIMITED | EJI | 2024-10-11 |
| 00813677022882 | PDT, Inc. | PDT, INC. | EJI | 2024-07-01 |
| 00813677022905 | PDT, Inc. | PDT, INC. | EJI | 2024-07-01 |
| 00813677022899 | PDT, Inc. | PDT, INC. | EJI | 2024-06-27 |
| 08800075607799 | OSUNG MND | OSUNG MND Co., Ltd. | EJI | 2024-03-05 |
| 08800075614391 | OSUNG MND | OSUNG MND Co., Ltd. | EJI | 2024-03-05 |
| 08800075614407 | OSUNG MND | OSUNG MND Co., Ltd. | EJI | 2024-03-05 |
| 08800075614421 | OSUNG MND | OSUNG MND Co., Ltd. | EJI | 2024-03-05 |
| 08800075624994 | OSUNG MND | OSUNG MND Co., Ltd. | EJI | 2024-03-05 |
| 08800075607812 | OSUNG MND | OSUNG MND Co., Ltd. | EJI | 2024-02-23 |
| 08800075626349 | OSUNG MND | OSUNG MND Co., Ltd. | EJI | 2024-02-23 |
| 08800075626356 | OSUNG MND | OSUNG MND Co., Ltd. | EJI | 2024-02-23 |
| 08800053042093 | DENOPS | DENTIS CO. ,LTD | EJI | 2024-01-23 |
| 00840326421741 | Astek | Young Innovations, Inc. | EJI | 2023-12-01 |
| 00840326421758 | Astek | Young Innovations, Inc. | EJI | 2023-12-01 |
| 20840326421769 | Astek | Young Innovations, Inc. | EJI | 2023-12-01 |
| 10840326421779 | Astek | Young Innovations, Inc. | EJI | 2023-12-01 |
| 10840326421786 | Astek | Young Innovations, Inc. | EJI | 2023-12-01 |
| 20840326421790 | Astek | Young Innovations, Inc. | EJI | 2023-12-01 |
| 10840326421809 | Astek | Young Innovations, Inc. | EJI | 2023-12-01 |
| 20840326421813 | Astek | Young Innovations, Inc. | EJI | 2023-12-01 |
| 20840326421820 | Astek | Young Innovations, Inc. | EJI | 2023-12-01 |
| 10840326421830 | Astek | Young Innovations, Inc. | EJI | 2023-12-01 |
| 10840326421847 | Astek | Young Innovations, Inc. | EJI | 2023-12-01 |
| 20840326421851 | Astek | Young Innovations, Inc. | EJI | 2023-12-01 |