PNP Femur
- Primary DI
- 00840194472616
- Brand
- PNP Femur
- Company
- ORTHOPEDIATRICS CORP.
- Model
- 01-1501-0093-S
- Catalog number
- 01-1501-0093-S
- Device description
- 13mm Opening Reamer
- Published
- 2025-05-28
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| HTO | Reamer | Orthopedic | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00840194472616 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00840194472616 | 00840194472616 | 840194472616 | 0840194472616 |
GMDN Terms
| Term | Definition |
|---|
| Medullary canal orthopaedic reamer shaft | A flexible cylindrical device intended to accept an orthopaedic reamer head on its distal end and used during a procedure to open and enlarge a medullary canal (e.g., in the femur), for the insertion of devices during prosthesis implantation or for fracture fixation. It is designed to be mounted onto an appropriate surgical tool for manual or powered rotation and is made of flexible materials (e.g., carbon fibre); it has a hollow centre so it can be fed over a guide, and devices to assist the procedure (e.g., drill guiding pin, manual driver) may be provided with the device. This is a single-use device. |
Regulatory Flags
- DUNS number
- 796416191
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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