FDA UDI
In Commercial Distribution
🇺🇸 United States
Cadwell Patch Electrode with Snap Connector
DI: 00840067102404
·
Model: 302300-200-024
·
CADWELL INDUSTRIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Cadwell Patch Electrode with Snap Connector
- Primary DI
- 00840067102404
- Version / Model
- 302300-200-024
- Company Name
- CADWELL INDUSTRIES, INC.
- Labeler DUNS
- 098554157
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-09-25
- Public Version
- 3
- Public Version Date
- 2018-06-11
- Public Version Status
- Update
- Public Device Record Key
- 011ade3a-72f7-45da-ae77-17ec07448516
Device Description
Electrode Leadwire w/Flat Snap Amb 61cm/24in 11/Pk
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| IKD | CABLE, ELECTRODE | Physical Medicine | 890.1175 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 11441 | Electromyographic needle electrode, single-use | A sterile electrical conducting device designed to be inserted percutaneously into muscle or nerve tissue to detect bioelectrical signal activity. It is a needle-like device (a needle electrode with an electrical connector at the proximal end) that is connected to an electromyograph (EMG) with a dedicated cable/lead. The EMG records the electrical signals and converts them into a readable graph format; it is not primarily intended for nerve stimulation. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840067102404 | GS1 |
Customer Contacts
- Phone
- +1(509)735-6481
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 24 | Inch |