FDA UDI
In Commercial Distribution
🇺🇸 United States
Three degrees
DI: 06976378040020
·
Model: Circular
·
Dong Guan Ou Kang Electronics CO.,LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Three degrees
- Primary DI
- 06976378040020
- Version / Model
- Circular
- Company Name
- Dong Guan Ou Kang Electronics CO.,LTD
- Labeler DUNS
- 554408363
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-08-08
- Public Version
- 1
- Public Version Date
- 2023-08-16
- Public Version Status
- New
- Public Device Record Key
- e4def046-8c3b-4440-8e40-39227057f54d
Device Description
Circular shape TENS/EMS Electrode Pads includes specification of Φ15, Φ20, Φ22, Φ25, Φ30, Φ32, Φ35, Φ40, Φ45, Φ50, Φ52, Φ55, Φ60, Φ64, Φ65, Φ70, Φ75, Φ80, Φ90, Φ100, Φ110, Φ115, Φ120, Φ130, Φ135, Φ150, Φ160
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| 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 | 06976378040020 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K181234 | 000 |