ORTHOMED
- Primary DI
- B8034701660
- Brand
- ORTHOMED
- Company
- ORTHO-MED, INC.
- Model
- OM 47-0166
- Device description
- LOWMAN BONE CLAMP 8" 1X1
- Published
- 2024-05-17
- 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 |
|---|
| HDX | Dilator, Vaginal |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| HDX | Dilator, Vaginal | Obstetrics/Gynecology | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| B8034701660 | Primary | HIBCC | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Bone holding forceps | A manual surgical instrument designed to grasp and hold a bone during an open surgical procedure. It is typically strongly constructed with a scissors-like design, which may or may not be self-retaining, and with ring handles or curved shank handles. It is made of high-grade stainless steel and is available in various sizes. The working end can have a wide variety of jaws designs, e.g., curved serrated jaws, straight toothed jaws, or profiled wrench-like jaws with grooves to provide extra grip of the bone. This is a reusable device. |
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags
- DUNS number
- 086618626
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- false
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- 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 |
|---|
| 00810142352307 | Bioteque America, Inc. | Bioteque America, Inc. | HDX | 2025-05-30 |
| 00810142352215 | Bioteque America, Inc. | Bioteque America, Inc. | HDX | 2025-05-29 |
| 00810142352222 | Bioteque America, Inc. | Bioteque America, Inc. | HDX | 2025-05-29 |
| 00810142352239 | Bioteque America, Inc. | Bioteque America, Inc. | HDX | 2025-05-29 |
| 00810142352246 | Bioteque America, Inc. | Bioteque America, Inc. | HDX | 2025-05-29 |
| 00810142352260 | Bioteque America, Inc. | Bioteque America, Inc. | HDX | 2025-05-29 |
| 00810142352277 | Bioteque America, Inc. | Bioteque America, Inc. | HDX | 2025-05-29 |
| 00810142352284 | Bioteque America, Inc. | Bioteque America, Inc. | HDX | 2025-05-29 |
| 00810142352291 | Bioteque America, Inc. | Bioteque America, Inc. | HDX | 2025-05-29 |
| 00810142352314 | Bioteque America, Inc. | Bioteque America, Inc. | HDX | 2025-05-12 |
| 00810142352253 | Bioteque America, Inc. | Bioteque America, Inc. | HDX | 2025-05-08 |
| 00860012225002 | Hope&Her Vaginal Dilators | LUJENA, INC. | HDX | 2024-11-15 |
| 04719894432236 | Bioteque Taiwan Ltd. | Bioteque Taiwan Ltd. | HDX | 2024-04-08 |
| 04719894432243 | Bioteque Taiwan Ltd. | Bioteque Taiwan Ltd. | HDX | 2024-04-08 |
| 04719894432250 | Bioteque Taiwan Ltd. | Bioteque Taiwan Ltd. | HDX | 2024-04-08 |
| 04719894432267 | Bioteque Taiwan Ltd. | Bioteque Taiwan Ltd. | HDX | 2024-04-08 |
| 04719894432274 | Bioteque Taiwan Ltd. | Bioteque Taiwan Ltd. | HDX | 2024-04-08 |
| 04719894432281 | Bioteque Taiwan Ltd. | Bioteque Taiwan Ltd. | HDX | 2024-04-08 |
| 04719894432298 | Bioteque Taiwan Ltd. | Bioteque Taiwan Ltd. | HDX | 2024-04-08 |
| 04719894432304 | Bioteque Taiwan Ltd. | Bioteque Taiwan Ltd. | HDX | 2024-04-08 |
| 04719894432205 | Bioteque Taiwan Ltd. | Bioteque Taiwan Ltd. | HDX | 2024-03-29 |
| 04719894432212 | Bioteque Taiwan Ltd. | Bioteque Taiwan Ltd. | HDX | 2024-03-29 |
| 04719894432229 | Bioteque Taiwan Ltd. | Bioteque Taiwan Ltd. | HDX | 2024-03-29 |
| 00842180186026 | ELMED | ELMED INCORPORATED | HDX | 2024-02-20 |
| 00842180184909 | ELMED | ELMED INCORPORATED | HDX | 2024-01-18 |
| 00842180184275 | ELMED | ELMED INCORPORATED | HDX | 2024-01-05 |
| 00842180183421 | ELMED | ELMED INCORPORATED | HDX | 2023-12-11 |
| 00842180183438 | ELMED | ELMED INCORPORATED | HDX | 2023-12-11 |
| 00842180183445 | ELMED | ELMED INCORPORATED | HDX | 2023-12-11 |
| 00842180183452 | ELMED | ELMED INCORPORATED | HDX | 2023-12-11 |