FDA UDI
In Commercial Distribution
🇺🇸 United States
SCANCOAT
DI: 10810050242735
·
Model: 9402
·
DOMICO MED-DEVICE, LLC
Product Codes
2
GMDN Terms
2
Identifiers
2
Pkg Device Count
2
Basic Information
- Brand Name
- SCANCOAT
- Primary DI
- 10810050242735
- Version / Model
- 9402
- Company Name
- DOMICO MED-DEVICE, LLC
- Labeler DUNS
- 081253414
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2020-09-24
- Public Version
- 1
- Public Version Date
- 2020-10-02
- Public Version Status
- New
- Public Device Record Key
- 533f0970-9e90-40ea-aa8d-db7237fe5dfb
Device Description
INFINIX MANDIBULAR SUPPORT PADS
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 |
|---|---|---|---|---|
| IWY | Holder, Head, Radiographic | Radiology | 892.1920 | 1 |
| 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 |
| 61132 | Radiological headrest | A non-sterile device intended to facilitate adequate positioning and immobilization of the patient's head and neck for reproducible positioning during diagnostic imaging procedures, image-guided surgical or interventional procedures, and/or radiation therapy procedures. The device is in the form of a frame, cushion, or preformed pad that is intended to directly contact the head, and which may be customizable for single-patient use. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00810050242738 | GS1 | ||||
| Primary | 10810050242735 | GS1 |