FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 06970341670108
·
Model: DS433/CSN2505
·
GMDASZ manufacturing Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- NA
- Primary DI
- 06970341670108
- Version / Model
- DS433/CSN2505
- Company Name
- GMDASZ manufacturing Co., Ltd.
- Labeler DUNS
- 529401134
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-12
- Public Version
- 5
- Public Version Date
- 2024-06-12
- Public Version Status
- Update
- Public Device Record Key
- 9269bd2e-d5f7-423f-8a26-809e2410a651
Device Description
1piece of DS433 and 2 pcs of CSN2505 in one pack
Device Characteristics
- Single Use
- No
- 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
- 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 |
|---|---|---|---|---|
| 65318 | Transcutaneous electrical stimulation electrode, reusable | 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 reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 6970341674137 | GS1 | bag | 10 | In Commercial Distribution | |
| Primary | 06970341670108 | GS1 | ||||
| Package | 6970341677114 | GS1 | carton | 400 | In Commercial Distribution |