FDA UDI
In Commercial Distribution
🇺🇸 United States
Control Room Interface
DI: 07090042052061
·
Model: CRI-1.0
·
Nordicneurolab AS
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Control Room Interface
- Primary DI
- 07090042052061
- Version / Model
- CRI-1.0
- Company Name
- Nordicneurolab AS
- Labeler DUNS
- 671280238
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-03-01
- Public Version
- 2
- Public Version Date
- 2020-06-02
- Public Version Status
- Update
- Public Device Record Key
- b8c2c345-5d65-40ed-9e89-f6cf8163dc40
Device Description
Control Room Interface (CRI) is part of Visual System HD. CRI is the interface unit for video signal in (HDMI) and eye tracking video out (HDMI). 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, Visual System HD.
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 Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| 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 | 07090042052061 | GS1 |
Customer Contacts
- Phone
- +4755707095
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K191032 | 000 |