WAVE Calcaneal Fracture Plate™
- Primary DI
- 00846832009930
- Brand
- WAVE Calcaneal Fracture Plate™
- Company
- TORNIER, INC.
- Model
- ZPFTS28
- Published
- 2015-09-26
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- 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 |
|---|
| 00846832009930 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00846832009930 | 00846832009930 | 846832009930 | 0846832009930 |
GMDN Terms
| Term | Definition |
|---|
| Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile | A non-sterile assembly of implantable devices designed for the stabilization of fractured/surgically-cut bones of the limbs (long bones), their appendages (hands, feet), pelvis, craniomaxillofacial bones, and/or for limb-joint fusion. It typically consists of a set of bone fixation plates, screws, wires, and pins made of materials that cannot be chemically degraded or absorbed via natural body processes (e.g., implant grade metal, surgical steel, titanium alloy, or carbon fibre). It may also include instruments for the attachment of the implants such as screwdrivers or drills. This device is intended to be sterilized prior to use. |
Device Sizes
| Type | Value | Unit |
|---|
| Length | 28 | Millimeter |
| Outer Diameter | 4 | Millimeter |
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags
- DUNS number
- 968990812
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- 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
- true
- Sterilization required before use
- true
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