FDA UDI
In Commercial Distribution
🇺🇸 United States
SMR STEMLESS
DI: 08033390100656
·
Model: 9013.55.435
·
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
- 08033390100656
- Version / Model
- 9013.55.435
- Catalog Number
- 9013.55.435
- 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
- ae4842f6-b245-4ad7-8f7d-d217b1b15df9
Device Description
SMR STEMLESS - Core Removal Reamer Medium
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
- No
- 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 |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|
| 60927 | Glenoid orthopaedic reamer | An orthopaedic surgical instrument designed to cut and resurface with precision the glenoid fossa for the acceptance of the glenoid fossa component of a shoulder joint prosthesis. The device is designed with a hemispherical head with an abrasive/cutting outer surface attached to a shaft for connection to a manual or powered handle. It is typically made of a high-grade stainless steel alloy and is available in various sizes. 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 | 08033390100656 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Medium |