OSUNG MND
- Primary DI
- 08800075604491
- Brand
- OSUNG MND
- Company
- OSUNG MND Co., Ltd.
- Model
- MT29
- Device description
- A hand-held manual dental instrument that has various forms of fine ridged cutting surfaces at its working end(s) designed to smooth and shape a tooth, an approximate bone (e.g., alveolar) and/or a dental restoration (e.g., filling). It is typically a one-piece instrument available in a variety of sizes and working end designs, including straight and curved ends, and often double-ended with a central handle; it is made of metal [e.g., stainless steel, titanium (Ti)]. This is a reusable device.
- Published
- 2024-02-19
- 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 |
|---|
| EJZ | Knife, Margin Finishing, Operative |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| EJZ | Knife, Margin Finishing, Operative | Dental | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 08800075604491 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|
| 08800075604491 | 08800075604491 | 8800075604491 |
GMDN Terms
| Term | Definition |
|---|
| Margin finishing dental file/rasp, reusable | A hand-held manual dental instrument that has various forms of fine ridged cutting surfaces at its working end(s) designed to smooth and shape a tooth, an approximate bone (e.g., alveolar) and/or a dental restoration (e.g., filling). It is typically a one-piece instrument available in a variety of sizes and working end designs, including straight and curved ends, and often double-ended with a central handle; it is made of metal [e.g., stainless steel, titanium (Ti)]. 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 |
|---|
| 08800075604484 | OSUNG MND | OSUNG MND Co., Ltd. | EJZ | 2024-02-26 |
| 08800075604460 | OSUNG MND | OSUNG MND Co., Ltd. | EJZ | 2024-02-19 |
| 08800075604477 | OSUNG MND | OSUNG MND Co., Ltd. | EJZ | 2024-02-19 |
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