FDA UDI
In Commercial Distribution
🇺🇸 United States
SMR System
DI: 08033390270694
·
Model: 1304.15.110
·
LIMACORPORATE SPA
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SMR System
- Primary DI
- 08033390270694
- Version / Model
- 1304.15.110
- Catalog Number
- 1304.15.110
- Company Name
- LIMACORPORATE SPA
- Labeler DUNS
- 432066322
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-02-22
- Public Version
- 1
- Public Version Date
- 2024-03-01
- Public Version Status
- New
- Public Device Record Key
- 9e6a9f6b-1dbf-421b-b5d0-5e2618938e14
Device Description
SMR System - Finned Stem Dia. 11 mm L. 60 mm
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 |
|---|---|---|---|---|
| HSD | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | Orthopedic | 888.3690 | 2 |
| KWT | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | Orthopedic | 888.3650 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48090 | Press-fit shoulder humeral stem prosthesis | A sterile implantable device designed to provide fixation within the proximal humerus and a site of attachment for a humeral head or humeral body prosthesis as part of a shoulder joint replacement. The device is made of metal [e.g., titanium (Ti), cobalt-chrome (Co-Cr), stainless steel] and is contoured to enable fixation by pressing the distal end into the cortex of the remaining natural humerus to achieve a mechanical interlock without the use of bone cement. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08033390270694 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K101263 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Dia. 11 mm L. 60 mm |