FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Scancoat
DI: 00810050244077
·
Model: 7-SCB
·
DOMICO MED-DEVICE, LLC
Product Codes
2
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Scancoat
- Primary DI
- 00810050244077
- Version / Model
- 7-SCB
- Company Name
- DOMICO MED-DEVICE, LLC
- Labeler DUNS
- 081253414
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-02-22
- Public Version
- 2
- Public Version Date
- 2023-02-22
- Public Version Status
- Update
- Public Device Record Key
- 9de3df8f-9e03-4447-a770-fc19395ff4ba
- Distribution End Date
- 2023-02-17
Device Description
SCANCOAT®, KIT, SMALL. Includes: 128-SCB - SCANCOAT®, WEDGE, 3" x 10" x 10" (00810050244053), 129-SCB - SCANCOAT®, WEDGE, 4.63 x 10” x 10” (00810050240321), 130-SCB - SCANCOAT®, WEDGE, 10" x 10" x 10" (00810050244060), 140-SCB - SCANCOAT®, WEDGE, 6" x 10" x 10" (00810050243629)
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
- Yes
- 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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KXJ | Table, Radiologic | Radiology | 892.1980 | 2 |
| CCX | Support, Patient Position | Anesthesiology | 868.6820 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41058 | Multifunction body cushion | A soft pillow or pad designed to provide support and comfort to a user's body part(s) in a variety of locations and positions, or to assist the user to fulfill a functional requirement involving various body parts. The device can be designed in a number of configurations that include a combined armrest-back support device, or an adjustable device. | No | Active |
| 61131 | Radiological general body-part positioner | A device intended to facilitate adequate positioning and immobilization of a patient’s body part during diagnostic imaging procedures, image-guided surgical or interventional procedures, and/or radiation therapy procedures; it is not dedicated to a specific part of the body. The device is in the form of a frame, board, cushion, or preformed pad 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 | 00810050244077 | GS1 |