ORTHOMED
- Primary DI
- B8034201500
- Brand
- ORTHOMED
- Company
- ORTHO-MED, INC.
- Model
- OM 42-0150
- Catalog number
- OM 42-0150
- Device description
- SAROT N.H. 10 1/2"
- Published
- 2021-06-02
- 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 |
|---|
| HYA | Forceps, Wire Holding |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| HYA | Forceps, Wire Holding | General, Plastic Surgery | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| B8034201500 | Primary | HIBCC | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Suturing needle holder, reusable | A hand-held manual surgical instrument designed to grasp a suture needle when pushing/pulling the needle and attached suture through tissue during suturing. It is typically made of metal and has short serrated jaws at the distal end to provide better grip of the needle. It is available in a wide variety of sizes and designs, such as: 1) a self-retaining, scissors-like design with ring handles at the proximal end; 2) a tweezers-like design with bowed, hinged handles that are operated by squeezing them together; and 3) a heavy-duty pincer-like design. Some types may utilize inserts made of hard materials (e.g., carbide) and include scissor blades. 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
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| 04049197473255 | RZ Medizintechnik GmbH | RZ-Medizintechnik GmbH | HYA | 2024-09-20 |
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| 07898506853717 | Quinelato | Schobell Industrial Ltda | HYA | 2023-07-07 |
| 07898506848676 | Quinelato | Schobell Industrial Ltda | HYA | 2023-07-05 |
| 07899798203310 | Schobell | Schobell Industrial Ltda | HYA | 2022-11-28 |
| 00840180508336 | General Instrument | ALPHATEC SPINE, INC. | HYA | 2022-10-13 |
| 00887482055410 | Symmetry Surgical® | SYMMETRY SURGICAL INC. | HYA | 2022-08-25 |
| 00850027837642 | StabilICE | ACUTUS MEDICAL, INC. | HYA | 2022-04-01 |
| 00850027837659 | StabilICE | ACUTUS MEDICAL, INC. | HYA | 2022-04-01 |
| 04250603736608 | LAZIC | Peter Lazic GmbH | HYA | 2021-12-22 |
| 04250603739487 | LAZIC | Peter Lazic GmbH | HYA | 2021-12-22 |
| 00850027837529 | StabilICE | ACUTUS MEDICAL, INC. | HYA | 2021-10-28 |
| 04250603736103 | LAZIC | Peter Lazic GmbH | HYA | 2021-07-02 |
| 04250603736110 | LAZIC | Peter Lazic GmbH | HYA | 2021-07-02 |
| 04250603736127 | LAZIC | Peter Lazic GmbH | HYA | 2021-07-02 |
| 04250603736134 | LAZIC | Peter Lazic GmbH | HYA | 2021-07-02 |
| 04250603736141 | LAZIC | Peter Lazic GmbH | HYA | 2021-07-02 |
| B8034101780 | ORTHOMED | ORTHO-MED, INC. | HYA | 2021-06-02 |
| B8034103330 | ORTHOMED | ORTHO-MED, INC. | HYA | 2021-06-02 |
| B8034104240 | ORTHOMED | ORTHO-MED, INC. | HYA | 2021-06-02 |
| B8034104260 | ORTHOMED | ORTHO-MED, INC. | HYA | 2021-06-02 |
| B8034104280 | ORTHOMED | ORTHO-MED, INC. | HYA | 2021-06-02 |
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