FDA UDI
In Commercial Distribution
🇺🇸 United States
TEMA Elbow
DI: 08033390140317
·
Model: 1575.14.030
·
LIMACORPORATE SPA
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- TEMA Elbow
- Primary DI
- 08033390140317
- Version / Model
- 1575.14.030
- Catalog Number
- 1575.14.030
- Company Name
- LIMACORPORATE SPA
- Labeler DUNS
- 432066322
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-05-24
- Public Version
- 2
- Public Version Date
- 2024-01-08
- Public Version Status
- Update
- Public Device Record Key
- 9ff3e2a2-f059-472b-9d4f-85631c24d186
Device Description
Ulnar Stem U6
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 |
|---|---|---|---|---|
| JDC | Prosthesis, Elbow, Constrained, Cemented | Orthopedic | 888.3150 | 2 |
| JDB | Prosthesis, Elbow, Semi-Constrained, Cemented | Orthopedic | 888.3160 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33173 | Metal-backed elbow ulna prosthesis | A sterile implantable device designed to replace the proximal ulna as part of an elbow joint replacement. The device is typically comprised of metal-backed polyethylene (PE) and its stem is usually coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. Fixation devices for implantation (e.g., screws) 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 | 08033390140317 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | U6 |