FDA UDI
In Commercial Distribution
🇺🇸 United States
NONE
DI: B006HGELS102
·
Model: NONE
·
Neurovision Medical Products, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
10
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Basic Information
- Brand Name
- NONE
- Primary DI
- B006HGELS102
- Version / Model
- NONE
- Catalog Number
- DSPHGELS-10
- Company Name
- Neurovision Medical Products, Inc.
- Labeler DUNS
- 182057401
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2025-02-12
- Public Version
- 3
- Public Version Date
- 2025-09-04
- Public Version Status
- Update
- Public Device Record Key
- 87b0994f-7aa2-484a-9712-73e88d9fa061
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ETN | Stimulator, Nerve | Ear, Nose, Throat | 874.1820 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61020 | Analytical non-scalp cutaneous electrode | An electrical conductor designed to be attached to the skin surface of a patient outside of the hair line (i.e., non-scalp) to conduct electrical signals to/from a parent device for electrophysiological recording/monitoring [e.g., electromyography (EMG), evoked potentials (EP), nerve conduction study (NCS), bioelectrical impedance]; it is not primarily intended for diagnostic electrocardiography (ECG) or electroencephalography (EEG). It typically consists of a small rectangular tab or cup/disk with a conductive surface, which may include a lead wire. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | B066HGELS1 | HIBCC | ||||
| Primary | B006HGELS102 | HIBCC | ||||
| Secondary | 00810155860356 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K110138 | 000 |