FDA UDI
In Commercial Distribution
🇺🇸 United States
Comprehensive Reverse Shoulder
DI: 00880304543188
·
Model: EP-115394
·
Biomet Orthopedics, LLC
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Comprehensive Reverse Shoulder
- Primary DI
- 00880304543188
- Version / Model
- EP-115394
- Catalog Number
- EP-115394
- Company Name
- Biomet Orthopedics, LLC
- Labeler DUNS
- 129278169
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-24
- Public Version
- 4
- Public Version Date
- 2020-11-03
- Public Version Status
- Update
- Public Device Record Key
- b3abb939-ab03-4402-986d-79704cde726b
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 |
|---|---|---|---|---|
| KWS | PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED | Orthopedic | 888.3660 | 2 |
| PAO | prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented | Orthopedic | 888.3660 | 2 |
| PHX | shoulder prosthesis, reverse configuration | Orthopedic | 888.3660 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48092 | Polyethylene reverse shoulder prosthesis cup | A sterile component of a reverse shoulder prosthesis that consists of a polyethylene (PE) cup intended to be attached to a humeral stem prosthesis, or humeral body component, and to articulate with the reverse shoulder head. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00880304543188 | GS1 |
Customer Contacts
- Phone
- +1(800)348-9500
- [email protected]
Premarket Submissions
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 44MM Ø 36MM Ø OF CURV +3MM STANDARD |