FDA UDI
In Commercial Distribution
🇺🇸 United States
Natus
DI: 08718375866337
·
Model: 027780
·
Technomed Engineering B.V.
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Natus
- Primary DI
- 08718375866337
- Version / Model
- 027780
- Company Name
- Technomed Engineering B.V.
- Labeler DUNS
- 418415568
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-07-15
- Public Version
- 4
- Public Version Date
- 2025-02-17
- Public Version Status
- Update
- Public Device Record Key
- 2aa907a5-311c-4b1f-b5b3-8c2ba6233a6f
Device Description
Ultra® Disposable Sensory Needle Electrode 15 x 0.70mm Active:8mm2
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 |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Package | 08718375866320 | GS1 | Pouch | 25 | In Commercial Distribution | |
| Primary | 08718375866337 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 0.70 | Millimeter | |
| Needle Gauge | 22 | Gauge | |
| Length | 15 | Millimeter |