FDA UDI
In Commercial Distribution
🇺🇸 United States
Neuroline Twisted Pair SubdermalNeurology Needle Electrodes
DI: 05707480038725
·
Model: 74612-100/1/20
·
Ambu A/S
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Neuroline Twisted Pair SubdermalNeurology Needle Electrodes
- Primary DI
- 05707480038725
- Version / Model
- 74612-100/1/20
- Catalog Number
- 74612-100/1/20
- Company Name
- Ambu A/S
- Labeler DUNS
- 305682023
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-22
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- fcd01797-c190-496f-b156-9d60f04773b4
Device Description
Ambu Neuroline Twisted Part Subdermal Needle Electrode Length: 12 mm (0.5") Leadwire Length: 100 cm (40") Black is paired with 5 different colours (blue, red, yellow, green, orange) 2 x 10 pairs of needles/2 pouches/1 box
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
- Labeling does not contain MRI Safety Information
- 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 |
|---|---|---|---|---|
| IKT | Electrode, needle, diagnostic electromyograph | Physical Medicine | 890.1385 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47714 | 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 05707480038732 | GS1 | 20 | In Commercial Distribution | ||
| Primary | 05707480038725 | GS1 | ||||
| Package | 05707480038749 | GS1 | 8 | In Commercial Distribution |
Customer Contacts
- Phone
- +14107686464
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 12 | Millimeter | |
| Length | 100 | Centimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 40 Degrees Celsius