OSUNG MND
- Primary DI
- 08800075622143
- Brand
- OSUNG MND
- Company
- OSUNG MND Co., Ltd.
- Model
- SRTVD60H
- Device description
- A manual dental device in the form of a strip coated with abrasive particles on one or both sides intended to be used for modifying the surface of a tooth or restoration during a dental procedure. It is commonly known as a polishing strip. This is a single-use device.
- Published
- 2024-03-04
- 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
Related Records
Product Codes
| Code | Name |
|---|---|
| EHM | Strip, Polishing Agent |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| EHM | Strip, Polishing Agent | Dental | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 08800075622143 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 08800075622143 | 08800075622143 | 8800075622143 |
GMDN Terms
| Term | Definition |
|---|---|
| Dental abrasive strip, single-use | A manual dental device in the form of a strip coated with abrasive particles on one or both sides intended to be used for modifying the surface of a tooth or restoration during a dental procedure. It is commonly known as a polishing strip. This is a single-use 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
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 08800075628350 | OSUNG MND | BSF-5P | 2025-06-23 | |
| 08800075627131 | OSUNG MND | SRTHD | 2025-04-11 | |
| 08800075626714 | OSUNG MND | DCM010F | 2024-03-22 | |
| 08800075626721 | OSUNG MND | DCM012F | 2024-03-22 | |
| 08800075626738 | OSUNG MND | DCM014F | 2024-03-22 | |
| 08800075626745 | OSUNG MND | DCM016F | 2024-03-22 | |
| 08800075626752 | OSUNG MND | DCL010F | 2024-03-22 | |
| 08800075626769 | OSUNG MND | DCL012F | 2024-03-22 | |
| 08800075626776 | OSUNG MND | DCL014F | 2024-03-22 | |
| 08800075626783 | OSUNG MND | DCL016F | 2024-03-22 | |
| 08800075626790 | OSUNG MND | DCXL014F | 2024-03-22 | |
| 08800075626806 | OSUNG MND | DCXL016F | 2024-03-22 | |
| 08800075626813 | OSUNG MND | TRL010F | 2024-03-22 | |
| 08800075626820 | OSUNG MND | TRL012F | 2024-03-22 | |
| 08800075626837 | OSUNG MND | TRL014F | 2024-03-22 | |
| 08800075626844 | OSUNG MND | TRXL012F | 2024-03-22 | |
| 08800075626851 | OSUNG MND | TRXL014F | 2024-03-22 | |
| 08800075626868 | OSUNG MND | PSM019C | 2024-03-22 | |
| 08800075626875 | OSUNG MND | FBL019EF | 2024-03-22 | |
| 08800075626882 | OSUNG MND | FBL025F | 2024-03-22 |
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