Neuroline SubdermalNeurology Needle Electrodes
- Primary DI
- 05707480135264
- Brand
- Neuroline SubdermalNeurology Needle Electrodes
- Company
- Ambu A/S
- Model
- 74512-100/24
- Catalog number
- 74512-100/24
- Device description
- Needle Electrode Length: 12 mm (0.5") Leadwire Length: 100 cm (40") Each box of 24 consists of 4 pieces in each of the colors: White, Green, Blue, Yel
- Published
- 2017-03-16
- 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 |
|---|
| 05707480135264 | Package | GS1 | 16 | In Commercial Distribution |
| 05707480135271 | Package | GS1 | 24 | In Commercial Distribution |
| 05707480135288 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|
| 05707480135264 | 05707480135264 | 5707480135264 |
| 05707480135271 | 05707480135271 | 5707480135271 |
| 05707480135288 | 05707480135288 | 5707480135288 |
GMDN Terms
| Term | Definition |
|---|
| Subdermal needle electrode | A sterile, multi-purpose electrical conductor inserted beneath the dermal layer of a patient's skin to record/monitor electrical activity (biopotentials) for physiological measurements [typically electroencephalography (EEG), electromyography (EMG), and evoked-potential) and often to provide electrical stimulation. It typically consists of thin shaft of stainless steel connected to a lead wire that terminates with a safety connector for attachment to recording/monitoring and stimulation systems. This is a single-use device. |
Device Sizes
| Type | Value | Unit |
|---|
| Length | 12 | Millimeter |
| Length | 100 | Centimeter |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Handling Environment Temperature | 10 Degrees Celsius | 25 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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