FDA UDI
In Commercial Distribution
🇺🇸 United States
Alpha-Stim Earclip Electrode Pad
DI: 00857869005031
·
Model: EEP
·
Electromedical Products International, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Alpha-Stim Earclip Electrode Pad
- Primary DI
- 00857869005031
- Version / Model
- EEP
- Company Name
- Electromedical Products International, Inc.
- Labeler DUNS
- 610954729
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-08-25
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- c6fbb0e2-ea67-42d6-a386-7380f2dc39db
Device Description
Alpha-Stim Earclip Electrode Pad
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| JXK | Stimulator, Cranial Electrotherapy | Neurology | 882.5800 | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61170 | Electrical probe/electrode conductive pad | A small, non-sterile device designed to facilitate electrical conduction between an electrical stimulation probe or electrode and the skin. It is typically contoured to fit on a particular type of probe/electrode and is made of an absorbent material (e.g., felt) that may be soaked in a conduction fluid. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00857869005031 | GS1 |