FDA UDI
In Commercial Distribution
🇺🇸 United States
N/A
DI: 04250307604326
·
Model: 533666
·
inomed Medizintechnik GmbH
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
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Basic Information
- Brand Name
- N/A
- Primary DI
- 04250307604326
- Version / Model
- 533666
- Company Name
- inomed Medizintechnik GmbH
- Labeler DUNS
- 340782259
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2024-07-01
- Public Version
- 1
- Public Version Date
- 2024-07-09
- Public Version Status
- New
- Public Device Record Key
- 7929057d-da1e-4cd2-b982-7537214f3561
Device Description
SDN electrodes 20/2000, stainless steel
Device Characteristics
- Single Use
- Yes
- 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
- MR Unsafe
- 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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ETN | Stimulator, Nerve | Ear, Nose, Throat | 874.1820 | 2 |
| GWF | Stimulator, Electrical, Evoked Response | Neurology | 882.1870 | 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 |
|---|---|---|---|---|---|---|
| Unit of Use | 14250307604323 | GS1 | ||||
| Primary | 04250307604326 | GS1 |