Neuroline InojectNeurology Needle Electrodes
- Primary DI
- 05707480001026
- Brand
- Neuroline InojectNeurology Needle Electrodes
- Company
- Ambu A/S
- Model
- 74435-40/10
- Catalog number
- 74435-40/10
- Device description
- Needle Electrode Length: 35 mm (1.4") Pre-attached Leadwire: 76 cm (30") Hub Colour: Blue
- Published
- 2016-09-22
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Product Codes
| Code | Name |
|---|
| IKT | Electrode, needle, diagnostic electromyograph |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| IKT | Electrode, Needle, Diagnostic Electromyograph | Physical Medicine | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 05707480001026 | Package | GS1 | 16 | In Commercial Distribution |
| 05707480023202 | Package | GS1 | 10 | In Commercial Distribution |
| 05707480024155 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|
| 05707480001026 | 05707480001026 | 5707480001026 |
| 05707480023202 | 05707480023202 | 5707480023202 |
| 05707480024155 | 05707480024155 | 5707480024155 |
GMDN Terms
| Term | Definition |
|---|
| 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. |
Device Sizes
| Type | Value | Unit |
|---|
| Length | 35 | Millimeter |
| Lumen/Inner Diameter | 0.4 | Millimeter |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Handling Environment Temperature | 10 Degrees Celsius | 25 Degrees Celsius | |
| Handling Environment Temperature | 10 Degrees Celsius | 40 Degrees Celsius | |
| Storage Environment Temperature | 10 Degrees Celsius | 25 Degrees Celsius | |
| Storage Environment Temperature | 10 Degrees Celsius | 40 Degrees Celsius | |
Regulatory Flags
- DUNS number
- 305682023
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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Other Devices Sharing Product Codes
ambuusa.com