FDA UDI
In Commercial Distribution
🇺🇸 United States
SPII Model Lubinus
DI: 04026575241644
·
Model: 127-741/26
·
WALDEMAR LINK GmbH & Co. KG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SPII Model Lubinus
- Primary DI
- 04026575241644
- Version / Model
- 127-741/26
- Catalog Number
- 127-741/26
- Company Name
- WALDEMAR LINK GmbH & Co. KG
- Labeler DUNS
- 315675488
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-11-01
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 961afa83-8258-464b-b9ac-a03479b5db8c
Device Description
Hip Prosthesis Stem - XL long neck,Taper 12/14
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
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| JDG | Prosthesis, Hip, Femoral Component, Cemented, Metal | Orthopedic | 888.3360 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34190 | Uncoated hip femur prosthesis, modular | A sterile implantable principal component of a total hip prosthesis (femoral component) typically 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 not coated with materials 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 is intended to be performed with bone cement. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04026575241644 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K953653 | 000 |