FDA UDI
In Commercial Distribution
🇺🇸 United States
SMR STEMLESS
DI: 08033390107792
·
Model: 1355.14.133
·
LIMACORPORATE SPA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- SMR STEMLESS
- Primary DI
- 08033390107792
- Version / Model
- 1355.14.133
- Catalog Number
- 1355.14.133
- Company Name
- LIMACORPORATE SPA
- Labeler DUNS
- 432066322
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-05-26
- Public Version
- 2
- Public Version Date
- 2024-01-08
- Public Version Status
- Update
- Public Device Record Key
- 898be413-2026-48ff-b1d9-13a5151f4e0f
Device Description
SMR STEMLESS - STEMLESS CORE # SMALL SHORT
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 |
|---|---|---|---|---|
| PKC | Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained | Orthopedic | 888.3660 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58951 | Metaphyseal anchor-fixed humeral head prosthesis | A sterile implantable artificial substitute for a diseased or injured humeral head. It is made of metal [e.g., titanium (Ti), cobalt-chrome (Co-Cr), stainless steel] and designed to be attached to a humeral metaphyseal anchor (a small metal framework that fills the metaphyseal vault) which provides cementless fixation to the proximal humerus. It is designed to articulate with the natural glenoid fossa, a glenoid fossa prosthesis, or a humeral head bipolar component as part of a shoulder replacement. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08033390107792 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | # SMALL SHORT |