FDA UDI
In Commercial Distribution
🇺🇸 United States
SMR Shoulder
DI: 08033390192996
·
Model: 9013.52.044
·
LIMACORPORATE SPA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- SMR Shoulder
- Primary DI
- 08033390192996
- Version / Model
- 9013.52.044
- Catalog Number
- 9013.52.044
- Company Name
- LIMACORPORATE SPA
- Labeler DUNS
- 432066322
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-01-15
- Public Version
- 1
- Public Version Date
- 2021-01-25
- Public Version Status
- New
- Public Device Record Key
- e8b0c998-4665-478e-9d29-5644fe4c695c
Device Description
SMR Shoulder - 140° Trial Reverse Humeral Body SHORT
Device Characteristics
- Single Use
- No
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LXH | Orthopedic Manual Surgical Instrument | Orthopedic | 888.4540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60935 | Humeral body prosthesis trial | A copy of a final humeral body prosthesis designed to be used before primary or revision implant surgery to validate the proper size of the permanent prosthesis required by the patient and to ensure its proper orientation and positioning. It connects to a humeral stem prosthesis and articulates with a standard humeral head prosthesis, or connects to a reverse shoulder prosthesis cup, and is typically made of metal and/or polymer. This is a reusable device intended to be sterilized prior to use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08033390192996 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | SHORT 140° |