FDA UDI
In Commercial Distribution
🇺🇸 United States
AS-Trodes
DI: 00857869005055
·
Model: AT7
·
Electromedical Products International, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- AS-Trodes
- Primary DI
- 00857869005055
- Version / Model
- AT7
- 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
- 3
- Public Version Date
- 2021-02-19
- Public Version Status
- Update
- Public Device Record Key
- 889af4f3-b418-448e-827a-1a24d8dbb1b0
Device Description
AS-Trodes
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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | Neurology | 882.5890 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35995 | Transcutaneous electrical stimulation electrode, single-use | An electrical conductor intended to be attached to a patient's skin (noninvasive) to provide therapeutic electrical stimuli through the body surface [e.g., transcutaneous electrical nerve stimulation (TENS), electrical muscle stimulation (EMS), cranial electrotherapy stimulation (CES)]. It is typically a flat, flexible, conductive pad with an adhesive (e.g., gel), or a preformed shape/mechanism designed for attachment to a particular body part (e.g., earclip), connected to a conductive wire. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00857869005055 | GS1 | ||||
| Package | 10857869005052 | GS1 | autobag | 10 | In Commercial Distribution | |
| Package | 20857869005059 | GS1 | case | 30 | In Commercial Distribution |