FDA UDI
In Commercial Distribution
🇺🇸 United States
Oakworks Medical
DI: 00817463022483
·
Model: Carbon Fiber Arm Board
·
OAKWORKS, INC.
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Oakworks Medical
- Primary DI
- 00817463022483
- Version / Model
- Carbon Fiber Arm Board
- Company Name
- OAKWORKS, INC.
- Labeler DUNS
- 130256837
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 3
- Public Version Date
- 2019-03-11
- Public Version Status
- Update
- Public Device Record Key
- 6fd44463-8436-443f-9c67-9a933e5182f3
Device Description
Carbon Fiber Arm Board, Fluoro + Wide + Pad
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MMZ | Table, Cystometric, Electric | Gastroenterology, Urology | 876.4890 | 2 |
| IXQ | Table, Radiographic, Stationary Top | Radiology | 892.1980 | 2 |
| IZZ | Table, Radiographic, Non-Tilting, Powered | Radiology | 892.1980 | 2 |
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 | 00817463022483 | GS1 |