FDA UDI
In Commercial Distribution
🇺🇸 United States
HYBRID(TM) GLENOID
DI: 00880304456341
·
Model: 406114
·
Biomet Orthopedics, LLC
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- HYBRID(TM) GLENOID
- Primary DI
- 00880304456341
- Version / Model
- 406114
- Catalog Number
- 406114
- Company Name
- Biomet Orthopedics, LLC
- Labeler DUNS
- 129278169
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-03-20
- Public Version
- 5
- Public Version Date
- 2022-02-16
- Public Version Status
- Update
- Public Device Record Key
- 4e8c75b9-053e-4564-b6b2-1d7688fb5884
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 |
|---|---|---|---|---|
| KWS | PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED | Orthopedic | 888.3660 | 2 |
| KWT | PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED | Orthopedic | 888.3650 | 2 |
| HWT | TEMPLATE | Orthopedic | 888.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58748 | Pure wool pillow | A device made of pure new wool, typically sheep's wool, intended to support the head, especially during rest and sleep, to help relieve medical ailments such as pain, muscle tension, poor blood circulation, and to provide comfort by improving overall mobility and warmth. It is available in various shapes and sizes. It is typically used for rheumatologic treatment after injury, inflammation of tendons, muscles, degenerative changes and pain syndrome in joints and spine, arthritic symptoms, migraine pain and neuralgia. It consists of a case with at least one side made of 100% wool filled with various materials (e.g., polyester fabric, memory foam, latex foam). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00880304456341 | GS1 |
Customer Contacts
- Phone
- +1(800)348-9500
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 4MM HYBRID(TM) GLENOID TRIAL, LARGE |