FDA UDI
In Commercial Distribution
🇺🇸 United States
Aequalis Resurfacing Head
DI: 03700386931802
·
Model: DWD064
·
TORNIER
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Aequalis Resurfacing Head
- Primary DI
- 03700386931802
- Version / Model
- DWD064
- Catalog Number
- DWD064
- Company Name
- TORNIER
- Labeler DUNS
- 260324876
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-08-08
- Public Version
- 1
- Public Version Date
- 2022-08-16
- Public Version Status
- New
- Public Device Record Key
- a0f4caa4-b063-482e-ad83-68fcc3c72693
Device Description
PIN - DO NOT IMPLANT
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HWE | INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT | General, Plastic Surgery | 878.4820 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47900 | Orthopaedic implant calibration pin | A cylindrical rod used preoperatively as a precision guide to align an orthopaedic implant aiming arm with, e.g., an intramedullary bone nail (femoral, humeral, and tibial) that will be implanted. It is inserted through the guiding locking holes of the adjustable aiming arm and its profiled distal tip is engaged into the locking holes of the intramedullary nail providing a given reference point whereby the drill guides and the rest of the aiming arm can be correctly set to correspond with the holes and measurements of the implant. It is typically made of high-grade stainless steel or synthetic materials. Several calibration pins will be used for this procedure. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03700386931802 | GS1 |
Customer Contacts
- Phone
- +330476613500
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 3 | Millimeter | |
| Length | 170 | Millimeter |