Innomed, Inc.
- Primary DI
- 00840277114440
- Brand
- Innomed, Inc.
- Company
- INNOMED, INC.
- Model
- 8031-01
- Catalog number
- 8031-01
- Device description
- Debris Shield without Reamer Slot without Case
- Published
- 2020-01-31
- 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 |
|---|---|
| LXH | Orthopedic Manual Surgical Instrument |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| LXH | Orthopedic Manual Surgical Instrument | Orthopedic | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00840277114440 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00840277114440 | 00840277114440 | 840277114440 | 0840277114440 |
GMDN Terms
| Term | Definition |
|---|---|
| Orthopaedic bone particle collector, reusable | A non-sterile device intended to be fitted to an orthopaedic rotary cutting tool (e.g., reamer) to collect bone debris created through bone resection during orthopaedic surgery. It is typically in the form of a cup-shaped attachment intended to prevent particulate bone entering the surgical wound. This is a reusable device intended to be sterilized prior to use. |
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags
- DUNS number
- 878427491
- 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
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 00840277133427 | Innomed, Inc. | 7325-00 | 7325-00 | 2026-03-20 |
| 00840277133403 | Innomed, Inc. | 4576-02-56 | 4576-02-56 | 2026-03-11 |
| 00840277133410 | Innomed, Inc. | 4576-56 | 4576-56 | 2026-03-11 |
| 00840277133359 | Innomed, Inc. | 4535-30 | 4535-30 | 2026-02-26 |
| 00840277133366 | Innomed, Inc. | 4535-90 | 4535-90 | 2026-02-26 |
| 00840277133373 | Innomed, Inc. | 3440-L | 3440-L | 2026-02-26 |
| 00840277133380 | Innomed, Inc. | 3440-R | 3440-R | 2026-02-26 |
| 00840277133182 | Innomed, Inc. | 2725-EU | 2725-EU | 2026-02-06 |
| 00840277133199 | Innomed, Inc. | 4090-EU | 4090-EU | 2026-02-06 |
| 00840277133205 | Innomed, Inc. | 4095-EU | 4095-EU | 2026-02-06 |
| 00840277133212 | Innomed, Inc. | 4105-EU | 4105-EU | 2026-02-06 |
| 00840277133229 | Innomed, Inc. | 4165-00-EU | 4165-00-EU | 2026-02-06 |
| 00840277133236 | Innomed, Inc. | 8840-EU | 8840-EU | 2026-02-06 |
| 00840277133243 | Innomed, Inc. | 1172 | 1172 | 2026-02-06 |
| 00840277133250 | Innomed, Inc. | 1173 | 1173 | 2026-02-06 |
| 00840277133267 | Innomed, Inc. | T1018-KT | T1018-KT | 2026-02-06 |
| 00840277133274 | Innomed, Inc. | T1019-KT | T1019-KT | 2026-02-06 |
| 00840277133281 | Innomed, Inc. | T1020-KT | T1020-KT | 2026-02-06 |
| 00840277133298 | Innomed, Inc. | T1021-KT | T1021-KT | 2026-02-06 |
| 00840277133304 | Innomed, Inc. | T1022-KT | T1022-KT | 2026-02-06 |
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