FDA UDI
In Commercial Distribution
🇺🇸 United States
Disposable Adhesive Surface Electrodes
DI: 18054655007630
·
Model: DENIS02025
·
SPES MEDICA SPA
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
400
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Basic Information
- Brand Name
- Disposable Adhesive Surface Electrodes
- Primary DI
- 18054655007630
- Version / Model
- DENIS02025
- Company Name
- SPES MEDICA SPA
- Labeler DUNS
- 514029771
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 400
- Record Status
- Published
- Publish Date
- 2025-11-21
- Public Version
- 1
- Public Version Date
- 2025-12-01
- Public Version Status
- New
- Public Device Record Key
- 45e37188-0ba6-49e3-b5da-aff9ba134d03
Device Characteristics
- Single Use
- Yes
- 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
- 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
- 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 |
|---|---|---|---|---|
| GXY | Electrode, Cutaneous | Neurology | 882.1320 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 11441 | Electromyographic needle electrode, single-use | A sterile electrical conducting device designed to be inserted percutaneously into muscle or nerve tissue to detect bioelectrical signal activity. It is a needle-like device (a needle electrode with an electrical connector at the proximal end) that is connected to an electromyograph (EMG) with a dedicated cable/lead. The EMG records the electrical signals and converts them into a readable graph format; it is not primarily intended for nerve stimulation. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 08054655007633 | GS1 | ||||
| Primary | 18054655007630 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K120494 | 000 |