ORTHOMED
- Primary DI
- B8032904300
- Brand
- ORTHOMED
- Company
- ORTHO-MED, INC.
- Model
- OM 29-0430
- Device description
- FINGER RING CUTTER 6 1/2"
- Published
- 2022-09-06
- 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 |
|---|
| FNS | Ring Cutter | General Hospital | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| B8032904300 | Primary | HIBCC | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Ring cutter | A manually-operated instrument designed for cutting rings and other jewellery from fingers or other body appendages (e.g., the penis) when difficult to remove by other means. It is typically a scissors-like instrument that brings a serrated cutting wheel blade to bear on a thin support which is slipped beneath the ring or item to be removed; the operator rotates the cutting wheel manually by turning an attached handle. 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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| 00190776381684 | Millennium | Avalign Technologies, Inc. | FNS | 2023-11-09 |
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| 00840183511913 | BR Surgical, LLC | BR Surgical, LLC | FNS | 2023-03-06 |
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| 00842331150968 | Novo Surgical Inc. | NOVO SURGICAL, INC. | FNS | 2022-11-12 |
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| 00842331136078 | Novo Surgical Inc. | NOVO SURGICAL, INC. | FNS | 2022-11-10 |
| 00887482073407 | Symmetry Surgical® | SYMMETRY SURGICAL INC. | FNS | 2022-09-16 |
| 00887482073384 | Symmetry Surgical | SYMMETRY SURGICAL INC. | FNS | 2022-09-16 |
| B8032904340 | ORTHOMED | ORTHO-MED, INC. | FNS | 2022-09-06 |