FDA UDI
In Commercial Distribution
🇺🇸 United States
SMR Shoulder
DI: 08033390038805
·
Model: Trial Adaptor
·
LIMACORPORATE SPA
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SMR Shoulder
- Primary DI
- 08033390038805
- Version / Model
- Trial Adaptor
- Catalog Number
- 9013.30.015
- Company Name
- LIMACORPORATE SPA
- Labeler DUNS
- 432066322
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-04-05
- Public Version
- 4
- Public Version Date
- 2019-02-07
- Public Version Status
- Update
- Public Device Record Key
- caca3150-fa8d-4576-98c7-28d11cea6a67
Device Description
Trial Adaptor STD Ecc.2mm
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 |
|---|---|---|---|---|
| KWT | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | Orthopedic | 888.3650 | 2 |
| HSD | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | Orthopedic | 888.3690 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61003 | Humeral head spacer prosthesis trial | A copy of a final humeral head spacer designed to be used before primary or revision implant surgery to validate the appropriate size of the permanent prosthesis required by the patient, and to ensure its proper orientation and positioning. It is disk-like in shape and 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 | 08033390038805 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K100858 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | # STD Ecc.2mm |