FDA UDI
In Commercial Distribution
🇺🇸 United States
ResponseGrips
DI: 07090042054010
·
Model: 4.0
·
Nordicneurolab AS
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ResponseGrips
- Primary DI
- 07090042054010
- Version / Model
- 4.0
- Company Name
- Nordicneurolab AS
- Labeler DUNS
- 671280238
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-05-22
- Public Version
- 5
- Public Version Date
- 2020-06-02
- Public Version Status
- Update
- Public Device Record Key
- 1f407c5e-995b-43a3-b712-038aa6fb8d0d
Device Description
The ResponseGrip is an MRI-safe patient response device, providing real-time feedback of a patient response. The ResponseGrip consists of two hand-held grips with two buttons each. By pressing the buttons the patient can respond to the presented stimulus. The ResponseGrip is connected to an optical-electrical adapter which converts light to electrical signals. The electrical signal is fed to the Stimulus PC by using standard PC communication interfaces.
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 Safe
- 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 |
|---|---|---|---|---|
| 62660 | Interactive-evaluation patient hand-controller | A hand-held electronic device intended to be used by a patient to respond to auditory and/or visual stimuli during an interactive medical evaluation (e.g., during functional magnetic resonance imaging, audiometry). It typically includes push buttons, and may include a dedicated system interface unit. It is intended to be integrated as part of a larger system but it is not intended to be used to change system settings. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07090042054010 | GS1 |
Customer Contacts
- Phone
- +4755707095
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K092253 | 000 |