FDA UDI
In Commercial Distribution
🇺🇸 United States
SMR TT Hybrid Glenoid
DI: 08033390121804
·
Model: 1379.59.211
·
LIMACORPORATE SPA
Product Codes
4
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SMR TT Hybrid Glenoid
- Primary DI
- 08033390121804
- Version / Model
- 1379.59.211
- Catalog Number
- 1379.59.211
- Company Name
- LIMACORPORATE SPA
- Labeler DUNS
- 432066322
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-07-27
- Public Version
- 1
- Public Version Date
- 2024-08-05
- Public Version Status
- New
- Public Device Record Key
- 2f0f4e0e-b17b-4c48-9331-b94c963383fc
Device Description
Hybrid Glenoid Baseplate Std +1 - Peg S
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 |
|---|---|---|---|---|
| MBF | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented | Orthopedic | 888.3670 | 2 |
| KWT | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | Orthopedic | 888.3650 | 2 |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | Orthopedic | 888.3660 | 2 |
| PHX | Shoulder Prosthesis, Reverse Configuration | Orthopedic | 888.3660 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36259 | Shoulder glenoid fossa prosthesis, prefabricated | An implantable, prefabricated component of a total shoulder prosthesis (glenoid component) designed to replace or repair the glenoid fossa; it is not a custom-made device. It is cup-like in shape and typically made of polyethylene (PE), but may be made of metal or a combination of PE and metal; it may include fixation devices (e.g., screws) for attachment to the scapula. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08033390121804 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K163397 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Std +1 - Peg S |