mahe medical GmbH
- Primary DI
- 04050659257481
- Brand
- mahe medical GmbH
- Company
- mahe medical gmbh
- Model
- 100-0510-009
- Device description
- TI DPL-Recon.Plate 3.5mm,str.,9 H., _x000D_128.5mm,locking plate,with combi-holes, _x000D_colour: blue
- Published
- 2019-11-05
- 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
- true
Product Codes
| Code | Name |
|---|
| HRS | Plate, fixation, bone |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| HRS | Plate, Fixation, Bone | Orthopedic | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 04050659257481 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|
| 04050659257481 | 04050659257481 | 4050659257481 |
GMDN Terms
| Term | Definition |
|---|
| Orthopaedic fixation plate, non-bioabsorbable, non-sterile | A non-sterile implantable sheet of firm material intended to be attached to fractured long bone fragments with screws to bridge and stabilize the fracture gap, and shield the site from stress as the bone heals; the material is not chemically degraded or absorbed by natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is typically used to treat traumatic or pathological orthopaedic fractures; it may also be used to temporarily augment bone following a lengthening procedure, or for arthrodesis (joint fusion). This device is intended to be sterilized prior to use. |
Regulatory Flags
- DUNS number
- 342243334
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- true
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- true
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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