FDA UDI
In Commercial Distribution
🇺🇸 United States
PADDLE, LEG POSITIONER, RIGHT
DI: 00880304406421
·
Model: 905041
·
Biomet Orthopedics, LLC
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- PADDLE, LEG POSITIONER, RIGHT
- Primary DI
- 00880304406421
- Version / Model
- 905041
- Catalog Number
- 905041
- Company Name
- Biomet Orthopedics, LLC
- Labeler DUNS
- 129278169
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-07-28
- Public Version
- 4
- Public Version Date
- 2020-05-25
- Public Version Status
- Update
- Public Device Record Key
- 443fec49-519d-472c-847e-4902da06eb6d
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
- Yes
- 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 |
|---|---|---|---|---|
| BWN | TABLE AND ATTACHMENTS, OPERATING-ROOM | General, Plastic Surgery | 878.4950 | 1 |
| KQZ | COMPONENT, TRACTION, NON-INVASIVE | Orthopedic | 888.5890 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40900 | Radiological arm/leg positioner | A device designed to ensure adequate positioning and immobilization of the patient's arms and/or legs during diagnostic imaging procedures, image-guided surgical or interventional procedures, and/or radiation therapy procedures. It may include various configurations such as a frame, board, cushion, preformed pad, or shoulder tension rope, strap, or handle grip that may also be used to facilitate reproducible positioning for serial imaging studies or serial radiation therapy treatments. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00880304406421 | GS1 |
Customer Contacts
- Phone
- +1(800)348-9500
- [email protected]