FDA UDI
In Commercial Distribution
🇺🇸 United States
DJO SURGICAL
DI: 00190446758907
·
Model: 425-91-015
·
Encore Medical, L.P.
Product Codes
4
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- DJO SURGICAL
- Primary DI
- 00190446758907
- Version / Model
- 425-91-015
- Company Name
- Encore Medical, L.P.
- Labeler DUNS
- 154074504
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-04-25
- Public Version
- 2
- Public Version Date
- 2024-01-10
- Public Version Status
- Update
- Public Device Record Key
- 5adb2556-a2fa-4f0c-bbe6-9140e6d956d8
Device Description
EMPOWR blade stem, Stem, Standard, Size 15
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| LPH | PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED | Orthopedic | 888.3358 | 2 |
| KWZ | Prosthesis, hip, constrained, cemented or uncemented, metal/polymer | Orthopedic | 888.3310 | 2 |
| KWY | Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented | Orthopedic | 888.3390 | 2 |
| LZO | Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented | Orthopedic | 888.3353 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33581 | Coated hip femur prosthesis, modular | A sterile implantable principal component of a total hip prosthesis (femoral component) designed to replace the femoral head and neck; the device is composed of two or more separate pieces (e.g., head, neck, and stem) designed to be joined and is coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. The device may be made of metal and/or ceramic materials. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation may be performed with or without bone cement. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00190446758907 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K223779 | 000 |