OSUNG MND
- Primary DI
- 08800075610089
- Brand
- OSUNG MND
- Company
- OSUNG MND Co., Ltd.
- Model
- HTK145
- Device description
- A hand-held, manual, open-surgery instrument designed to grasp, manipulate, dissect, and/or clamp soft-tissues (e.g., organs, blood vessels); it is not intended for grasping/clamping bone or teeth, nor is it dedicated to ophthalmic surgery and is not a dedicated biopsy device. It has a scissors-like hinged design with ring handles and blades (non-cutting) that may be available in a range of sizes or designs. It may be intended for use at a specific anatomy. This is a reusable device intended to be sterilized prior to use.
- Published
- 2024-02-26
- 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 |
|---|---|
| EMD | Hemostat, Surgical |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| EMD | Hemostat, Surgical | Dental | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 08800075610089 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 08800075610089 | 08800075610089 | 8800075610089 |
GMDN Terms
| Term | Definition |
|---|---|
| Surgical soft-tissue manipulation forceps, scissors-like, reusable | A hand-held, manual, open-surgery instrument designed to grasp, manipulate, dissect, and/or clamp soft-tissues (e.g., organs, blood vessels); it is not intended for grasping/clamping bone or teeth, nor is it dedicated to ophthalmic surgery and is not a dedicated biopsy device. It has a scissors-like hinged design with ring handles and blades (non-cutting) that may be available in a range of sizes or designs. It may be intended for use at a specific anatomy. This is a reusable device intended to be sterilized prior to use. |
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 |
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| G1493806608 | TBS Dental | ACME ENTERPRISE. | EMD | 2026-03-02 |
| G1493807609 | TBS Dental | ACME ENTERPRISE. | EMD | 2026-03-02 |
| 00841336101630 | Salvin Dental Specialties | SALVIN DENTAL SPECIALTIES, LLC | EMD | 2025-09-28 |
| 00841336101647 | Salvin Dental Specialties | SALVIN DENTAL SPECIALTIES, LLC | EMD | 2025-09-28 |
| 00840343726287 | GEN2 | SURGIX MEDICAL LLC | EMD | 2025-06-09 |
| 00840343726379 | GEN2 | SURGIX MEDICAL LLC | EMD | 2025-06-09 |
| 00840343726386 | GEN2 | SURGIX MEDICAL LLC | EMD | 2025-06-09 |
| 00840343726393 | GEN2 | SURGIX MEDICAL LLC | EMD | 2025-06-09 |
| 00840343725884 | GEN2 | SURGIX MEDICAL LLC | EMD | 2025-03-07 |
| 00842517111417 | Karl Schumacher | Karl Schumacher Dental, LLC | EMD | 2025-02-05 |
| 00842517111424 | Karl Schumacher | Karl Schumacher Dental, LLC | EMD | 2025-02-05 |
| 00842517112209 | Karl Schumacher | Karl Schumacher Dental, LLC | EMD | 2025-02-05 |
| 00842517112216 | Karl Schumacher | Karl Schumacher Dental, LLC | EMD | 2025-02-05 |
| D928140051190 | HEMOSTAT CRAFOORD SLIGHT CURVED 19CM | W.H. Holden, Inc. | EMD | 2024-12-18 |
| 00840343725099 | GEN2 | SURGIX MEDICAL LLC | EMD | 2024-11-07 |
| 00840343724702 | GEN2 | SURGIX MEDICAL LLC | EMD | 2024-10-25 |
| 00840343724061 | GEN2 | SURGIX MEDICAL LLC | EMD | 2024-10-01 |
| 00840343724078 | GEN2 | SURGIX MEDICAL LLC | EMD | 2024-10-01 |
| 00840343723255 | GEN2 | SURGIX MEDICAL LLC | EMD | 2024-09-18 |
| 00840343723392 | GEN2 | SURGIX MEDICAL LLC | EMD | 2024-09-12 |
| 00348783001440 | Premier Hemostat | PREMIER DENTAL PRODUCTS COMPANY | EMD | 2024-08-01 |
| 00348783001457 | Premier Hemostat | PREMIER DENTAL PRODUCTS COMPANY | EMD | 2024-08-01 |
| 00840343722913 | GEN2 | SURGIX MEDICAL LLC | EMD | 2024-07-31 |
| 00840343722968 | GEN2 | SURGIX MEDICAL LLC | EMD | 2024-07-31 |
| 00840343722999 | GEN2 | SURGIX MEDICAL LLC | EMD | 2024-07-31 |
| 00813677023230 | PDT, Inc. | PDT, INC. | EMD | 2024-07-02 |
| 04049197054799 | RZ Medizintechnik GmbH | RZ-Medizintechnik GmbH | EMD | 2024-07-01 |
| 00840343722814 | GEN2 | SURGIX MEDICAL LLC | EMD | 2024-06-28 |
| 04049197206495 | RZ Medizintechnik GmbH | RZ-Medizintechnik GmbH | EMD | 2024-06-28 |
| 04049197206693 | RZ Medizintechnik GmbH | RZ-Medizintechnik GmbH | EMD | 2024-06-28 |