FDA UDI
In Commercial Distribution
🇺🇸 United States
CEMENTED CUPS
DI: 08033390012805
·
Model: Standard Cup
·
LIMACORPORATE SPA
Product Codes
4
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CEMENTED CUPS
- Primary DI
- 08033390012805
- Version / Model
- Standard Cup
- Catalog Number
- 5618.50.010
- Company Name
- LIMACORPORATE SPA
- Labeler DUNS
- 432066322
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-07-31
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 3ca05ed5-08c9-49cb-a83b-aaddb93cdb38
Device Description
Cemented cups (UHMWPE) Dia. 44 for head dia28mm
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
- 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 |
|---|---|---|---|---|
| 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 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | Orthopedic | 888.3350 | 2 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Orthopedic | 888.3358 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34076 | Polyethylene acetabulum prosthesis | A sterile implantable principal component of a total hip prosthesis (acetabular component) designed to replace or repair the acetabulum. The component is of a one-piece construction and is made entirely of polyethylene (polyethylene cup); it may include fixation devices (e.g., screws) for attachment to the body. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08033390012805 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K112158 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Dia. 44mm For Heads 28mm |