FDA UDI
In Commercial Distribution
🇺🇸 United States
NONE
DI: B006PSS26DF52
·
Model: NONE
·
Neurovision Medical Products, Inc.
Product Codes
2
GMDN Terms
2
Identifiers
3
Pkg Device Count
5
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Basic Information
- Brand Name
- NONE
- Primary DI
- B006PSS26DF52
- Version / Model
- NONE
- Catalog Number
- DSPPSS26DF-5
- Company Name
- Neurovision Medical Products, Inc.
- Labeler DUNS
- 182057401
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 9
- Public Version Date
- 2025-09-04
- Public Version Status
- Update
- Public Device Record Key
- 33ccb071-1e46-4305-9ee4-d3afefeb6dcf
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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 |
|---|---|---|---|---|
| IKT | Electrode, Needle, Diagnostic Electromyograph | Physical Medicine | 890.1385 | 2 |
| ETN | Stimulator, Nerve | Ear, Nose, Throat | 874.1820 | 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 |
| 61088 | Aspiration nerve-locating system probe | A sterile, hand-held surgical instrument intended to apply a controlled electrical stimulus to a specific body site to locate nerves during surgery and for diagnostic purposes [electromyography (EMG)], as well as to provide a dry surgical field via suction cannula. It is typically used in open surgical procedures and is intended to be connected to an appropriate EMG pulse generating and recording device and a source of suction. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B006PSS26DF52 | HIBCC | ||||
| Unit of Use | B006PSS26DF1 | HIBCC | ||||
| Secondary | 00810155862152 | GS1 |