FDA UDI
In Commercial Distribution
🇺🇸 United States
TEMA Elbow
DI: 08033390128865
·
Model: 1590.15.010
·
LIMACORPORATE SPA
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- TEMA Elbow
- Primary DI
- 08033390128865
- Version / Model
- 1590.15.010
- Catalog Number
- 1590.15.010
- Company Name
- LIMACORPORATE SPA
- Labeler DUNS
- 432066322
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-05-11
- Public Version
- 2
- Public Version Date
- 2024-01-08
- Public Version Status
- Update
- Public Device Record Key
- b70b6a54-a9b8-44ed-825c-76e2159fde87
Device Description
Axle Small
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 |
|---|---|---|---|---|
| JDB | Prosthesis, Elbow, Semi-Constrained, Cemented | Orthopedic | 888.3160 | 2 |
| JDC | Prosthesis, Elbow, Constrained, Cemented | Orthopedic | 888.3150 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40124 | Hinged total elbow prosthesis | A sterile implantable artificial substitute for an elbow joint designed to replace the articulating surfaces of the damaged (e.g., fractured) and/or degenerative (e.g., arthritic) joint. It includes humeral and ulnar components, typically with parts made of metal and polyethylene (PE), that form a hinge at articulation. The device may include fixation devices (e.g., screws) for implantation and may be implanted with or without bone cement. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08033390128865 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Small |