FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Elitone
DI: 00851096008001
·
Model: EE-1002
·
ELIDAH, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
5
Basic Information
- Brand Name
- Elitone
- Primary DI
- 00851096008001
- Version / Model
- EE-1002
- Company Name
- ELIDAH, INC.
- Labeler DUNS
- 079300140
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2019-04-01
- Public Version
- 3
- Public Version Date
- 2021-04-09
- Public Version Status
- Update
- Public Device Record Key
- a72b6f76-1787-4592-92eb-d5dd9aeab32e
- Distribution End Date
- 2019-04-01
Device Description
Elitone GelPads are transcutaneous electrodes to be used with the Elitone Device.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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 |
|---|---|---|---|---|
| QAJ | Cutaneous Electrode Stimulator For Urinary Incontinence | Gastroenterology, Urology | 876.5330 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65017 | Transcutaneous incontinence-control electrical stimulator electrode pad | A noninvasive electrical conductor which is a component of a transcutaneous incontinence-control electrical stimulation system intended for the treatment of urinary and/or faecal incontinence through the transcutaneous (noninvasive) application of electrical stimuli to the muscles of the pelvic floor to induce Kegel-like contractions. It connects to an external pulse generator (via a cable or wirelessly) and is in the form of a skin gel pad with surface electrodes designed to be placed on the pubic area. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00851096008001 | GS1 | ||||
| Unit of Use | 00851096008025 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K183585 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 41 – 80 Degrees Fahrenheit