OSUNG MND
- Primary DI
- 08800075621269
- Brand
- OSUNG MND
- Company
- OSUNG MND Co., Ltd.
- Model
- MICSA10
- Device description
- A flat surgical cutting instrument, usually made of high-grade stainless steel, with a serrated edge and designed for attachment to a dedicated powered saw used for cutting bone/tissue during orthopaedic or oral surgery; it is not dedicated to cutting through the sternum (i.e., not a sternum saw blade). This device is designed with the cutting teeth arranged in an arc or on a flat plane pointing directly forward at its distal end to cut in a rapid oscillating (circular/arc-shaped) motion; it is not intended to perform a sagittal motion. This is a reusable device.
- Published
- 2024-02-21
- 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 |
|---|---|
| GFA | Blade, Saw, General & Plastic Surgery, Surgical |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| GFA | Blade, Saw, General & Plastic Surgery, Surgical | General, Plastic Surgery | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 08800075621269 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 08800075621269 | 08800075621269 | 8800075621269 |
GMDN Terms
| Term | Definition |
|---|---|
| Surgical saw blade, oscillating, reusable | A flat surgical cutting instrument, usually made of high-grade stainless steel, with a serrated edge and designed for attachment to a dedicated powered saw used for cutting bone/tissue during orthopaedic or oral surgery; it is not dedicated to cutting through the sternum (i.e., not a sternum saw blade). This device is designed with the cutting teeth arranged in an arc or on a flat plane pointing directly forward at its distal end to cut in a rapid oscillating (circular/arc-shaped) motion; it is not intended to perform a sagittal motion. 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
| 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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