FDA UDI
In Commercial Distribution
🇺🇸 United States
Blue Diamond
DI: 15060797551118
·
Model: BD080-FWa
·
David Scott Company
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Blue Diamond
- Primary DI
- 15060797551118
- Version / Model
- BD080-FWa
- Catalog Number
- BD080-FWa
- Company Name
- David Scott Company
- Labeler DUNS
- 073814568
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-07-07
- Public Version
- 1
- Public Version Date
- 2022-07-15
- Public Version Status
- New
- Public Device Record Key
- d1257e75-7009-477c-a955-04a4a9906dfc
Device Description
Adjustable Foot Board to be attached to the end of a surgical table. The footboard can be installed vertically or horizontally to suit the need. It has flat bars that adjust in & out for various table widths. From 20" to 22". The footboard can support up to 350 lbs. and includes a foam pad. The surface areas is 20" x 12.5".
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| CCX | Support, Patient Position | Anesthesiology | 868.6820 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62856 | Leg intraoperative repositioning support | A mechanical device intended to be used to help support and lift the weight of a patient’s leg in its intraoperative positioner when the leg needs to be repositioned during an orthopaedic procedure. It is a floor-standing support with a spring mechanism and is designed to be attached to the leg positioner affixed to the operating table. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 15060797551118 | GS1 |
Customer Contacts
- Phone
- 508-875-3333
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 20 | Inch | |
| Length | 12.5 | Inch |