FDA UDI
In Commercial Distribution
🇺🇸 United States
Neuroguard
DI: 08720791370503
·
Model: S41-638/02
·
Technomed Engineering B.V.
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Neuroguard
- Primary DI
- 08720791370503
- Version / Model
- S41-638/02
- Company Name
- Technomed Engineering B.V.
- Labeler DUNS
- 418415568
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-09-28
- Public Version
- 4
- Public Version Date
- 2025-02-17
- Public Version Status
- Update
- Public Device Record Key
- 4ee9b896-2b7a-421e-9680-1636fc377a5d
Device Description
Disposable Subdermal Needle Electrode, single; 14x0.38mm 1.5m wire 4x6 colors 24pcs
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
- No
- 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 |
|---|---|---|---|---|
| GXZ | Electrode, Needle | Neurology | 882.1350 | 2 |
| 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 | 08720791370510 | GS1 | Shelf box | 24 | In Commercial Distribution | |
| Primary | 08720791370503 | GS1 |
Customer Contacts
- Phone
- +31434086868
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 14 | Millimeter | |
| Outer Diameter | 0.38 | Millimeter |