ORTHOMED
- Primary DI
- B8034701540
- Brand
- ORTHOMED
- Company
- ORTHO-MED, INC.
- Model
- OM 47-0154
- Device description
- LOWMAN BONE CLAMP 7 1/4" 1X2
- 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 Code Classifications
| Code | Device | Specialty | Class |
|---|
| HXD | Clamp | General, Plastic Surgery | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| B8034701540 | 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 |
|---|
| 00192896122680 | Schroeder Vulsellum Bone Clamp | SONTEC INSTRUMENTS, INC. | HXD | 2026-03-10 |
| B356JD259280 | American Medicals | American Medicals | HXD | 2026-03-09 |
| 00190776416706 | Millennium | Avalign Technologies, Inc. | HXD | 2026-02-20 |
| 00190776415877 | Millennium | Avalign Technologies, Inc. | HXD | 2026-02-04 |
| 00810123209781 | Adler Instrument Company | Adler, Inc. | HXD | 2026-01-28 |
| 00810123209798 | Adler Instrument Company | Adler, Inc. | HXD | 2026-01-28 |
| 00841013124532 | American Eagle Instruments | AMERICAN EAGLE INSTRUMENTS, INC. | HXD | 2026-01-05 |
| 00841013124549 | American Eagle Instruments | AMERICAN EAGLE INSTRUMENTS, INC. | HXD | 2026-01-05 |
| 00841013124556 | American Eagle Instruments | AMERICAN EAGLE INSTRUMENTS, INC. | HXD | 2026-01-05 |
| 00841013124563 | American Eagle Instruments | AMERICAN EAGLE INSTRUMENTS, INC. | HXD | 2026-01-05 |
| 00888480670728 | Timberline Lateral Fusion System | Highridge Medical, LLC | HXD | 2025-12-18 |
| 05060624126697 | CS Fixed Blade Clamp | CARE SURGICAL LIMITED | HXD | 2025-12-17 |
| 03662663196741 | Alpine XC Adjustable Fusion System | Highridge Medical, LLC | HXD | 2025-12-15 |
| 03662663196758 | Alpine XC Adjustable Fusion System | Highridge Medical, LLC | HXD | 2025-12-15 |
| 03662663196796 | Alpine XC Adjustable Fusion System | Highridge Medical, LLC | HXD | 2025-12-15 |
| 09421038410479 | Enztec Inverted Premium Patella Clamp | ENZTEC LIMITED | HXD | 2025-12-11 |
| 09421038410486 | Enztec Premium Cement Clamp - Rotating | ENZTEC LIMITED | HXD | 2025-12-11 |
| 00840277133113 | Innomed, Inc. | INNOMED, INC. | HXD | 2025-12-02 |
| 00840338603685 | Tornier HRS Max | TORNIER, INC. | HXD | 2025-11-18 |
| 00840338603944 | Tornier HRS Max | TORNIER, INC. | HXD | 2025-11-18 |
| 03662663137027 | Polaris 4.75 Deformity System | Highridge Medical, LLC | HXD | 2025-11-14 |
| 00840277133038 | Innomed, Inc. | INNOMED, INC. | HXD | 2025-11-12 |
| 00885556768471 | EVOS | Smith & Nephew, Inc. | HXD | 2025-11-12 |
| 00885556908846 | EVOS | Smith & Nephew, Inc. | HXD | 2025-11-11 |
| 00885556911112 | EVOS | Smith & Nephew, Inc. | HXD | 2025-11-11 |
| 00885556911129 | EVOS | Smith & Nephew, Inc. | HXD | 2025-11-11 |
| 00885556911136 | EVOS | Smith & Nephew, Inc. | HXD | 2025-11-11 |
| 00885556911143 | EVOS | Smith & Nephew, Inc. | HXD | 2025-11-11 |
| 00885556911150 | EVOS | Smith & Nephew, Inc. | HXD | 2025-11-11 |
| 00885556911167 | EVOS | Smith & Nephew, Inc. | HXD | 2025-11-11 |