FDA UDI
In Commercial Distribution
🇺🇸 United States
Blue Diamond
DI: 15060797552306
·
Model: BD800
·
David Scott Company
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Blue Diamond
- Primary DI
- 15060797552306
- Version / Model
- BD800
- Catalog Number
- BD800
- 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
- fd6e85cb-2b27-42db-ad37-184c884b9b82
Device Description
Patient Restraint Strap made of fiber reinforced rubber. Has a foam mid panel with two airplane style buckles to adjust strap length. Conductive and latex free. Extremely durable and easily cleaned
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 |
|---|---|---|---|---|
| 63966 | Medical table restraint anchor | A device intended to be fixed to an operating/radiological table to provide a firmly secure point of attachment for a non-rigid restraint (e.g., strap, band, fabric sheet) to help achieve patient positioning and stabilization during a medical procedure. It may be in the form of a piece of flat material with double-sided adhesive, or a rigid sliding pad/plate that is attached to or fits into a matching slot on the medical table or table rails. Disposable positioners/restraints may be included with the device. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 15060797552306 | GS1 |
Customer Contacts
- Phone
- 508-875-3333
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 2 | Inch | |
| Length | 96 | Inch |