FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Cadwell Patch Electrode with Snap Connector
DI: 00840067102497
·
Model: 302696-000
·
CADWELL INDUSTRIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Cadwell Patch Electrode with Snap Connector
- Primary DI
- 00840067102497
- Version / Model
- 302696-000
- Company Name
- CADWELL INDUSTRIES, INC.
- Labeler DUNS
- 098554157
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-12-22
- Public Version
- 5
- Public Version Date
- 2024-01-09
- Public Version Status
- Update
- Public Device Record Key
- daab19b6-ba1f-4115-a143-4513689680ce
- Distribution End Date
- 2024-01-01
Device Description
Electrode Leadwire w/Flat Snap Amb 60 in
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
- No
- 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 |
|---|---|---|---|---|
| DSA | CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR) | Cardiovascular | 870.2900 | 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 | 00840067102497 | GS1 |
Customer Contacts
- Phone
- +1(509)735-6481
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K942321 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 60 | Inch |