FDA UDI
In Commercial Distribution
🇺🇸 United States
COMBY EEG CAP
DI: 03858894153428
·
Model: Bypass electrodes Ag/AgCl, red
·
PAMEL d.o.o.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- COMBY EEG CAP
- Primary DI
- 03858894153428
- Version / Model
- Bypass electrodes Ag/AgCl, red
- Catalog Number
- BYP10R
- Company Name
- PAMEL d.o.o.
- Labeler DUNS
- 643949162
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-08-16
- Public Version
- 1
- Public Version Date
- 2023-08-24
- Public Version Status
- New
- Public Device Record Key
- f5e98298-d123-4e30-9920-056eb2345466
Device Description
Bypass electrodes Ag/AgCl, red
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| GXY | Electrode, Cutaneous | Neurology | 882.1320 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47713 | Analytical scalp electrode, reusable | A noninvasive electrical conductor designed to be attached to the scalp surface of a patient to transmit changes in the electrical potential of various areas of the brain for recording/monitoring by a connected parent device [i.e., an electroencephalograph (EEG), sleep, or evoked potential recording device]. It typically consists of a small cup/disk/star with a conductive surface (e.g., tin, gold, silver, titanium, conductive plastic) and may include a length of insulated connecting wire; it may be available as a set of multiple electrodes (e.g., EEG electrodes) however it is not a preconfigured EEG cap. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03858894153428 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K211315 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from direct sunlight