FDA UDI
In Commercial Distribution
🇺🇸 United States
Coil Mounted Display
DI: 07090042052016
·
Model: CMD 2.3
·
Nordicneurolab AS
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Coil Mounted Display
- Primary DI
- 07090042052016
- Version / Model
- CMD 2.3
- Company Name
- Nordicneurolab AS
- Labeler DUNS
- 671280238
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 5
- Public Version Date
- 2020-06-02
- Public Version Status
- Update
- Public Device Record Key
- 6fe320cc-5977-4b47-b3e8-280dff12822c
Device Description
Coil Mounted Display is part of NordicNeuroLab’s VisualSystem. The VisualSystem allows video signals from the stimulus presentation PC to enter the shielded scanner room and to be presented to the patient through a set of coil-mounted displays or by an in-room LCD monitor. Coil Mounted Display is a flexible solution for presenting visual stimuli inside the MR scanner, which is based on OLED technology.
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
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|
| LNH | System, Nuclear Magnetic Resonance Imaging | Radiology | 892.1000 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35373 | Visual stimulator | An electronic device used to apply visual stimuli (e.g., shifting patterns of light) to a patient's eyes. This device typically presents light to the eye through an optical system (optical stimulator), or light is viewed directly from an illuminated screen (direct-view stimulator), or light-emitting diode (LED) stimulating goggles. It is typically used as a component of several other devices such as refractors, scanning ophthalmoscopes, visual evoked potential (VEP) recording systems, or an electroretinograph (ERG). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07090042052016 | GS1 |
Customer Contacts
- Phone
- +4755707095
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K092253 | 000 |