FDA UDI
In Commercial Distribution
🇺🇸 United States
Nerveäna+®
DI: B006NVPTKITDCSWF52
·
Model: NONE
·
NEUROVISION MEDICAL PRODUCTS, INC.
Product Codes
3
GMDN Terms
2
Identifiers
3
Pkg Device Count
5
Basic Information
- Brand Name
- Nerveäna+®
- Primary DI
- B006NVPTKITDCSWF52
- Version / Model
- NONE
- Company Name
- NEUROVISION MEDICAL PRODUCTS, INC.
- Labeler DUNS
- 182057401
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2024-02-01
- Public Version
- 1
- Public Version Date
- 2024-02-09
- Public Version Status
- New
- Public Device Record Key
- 0d7ddec6-afc3-4424-83fd-6021dfd5d242
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- 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 |
| GXZ | Electrode, Needle | Neurology | 882.1350 | 2 |
| ETN | Stimulator, Nerve | Ear, Nose, Throat | 874.1820 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62208 | Electromyographic endotracheal tube electrode | A sterile electrical-conducting strip intended to be attached to an endotracheal tube to conduct the electromyographic (EMG) activity of the laryngeal and vocal cord musculature while the tube is in situ. It is used to assess the status of the nerves supplying the laryngeal musculature during surgery. It is intended to be connected to an appropriate EMG measuring/recording device, and may be supplied with a ground electrode. This is a single-use device. | No | Active |
| 61089 | Nerve-locating system probe, single-use | A hand-held surgical instrument intended to function as an electrical conductor to locate a nerve during open surgery, and for diagnostic purposes [electromyography (EMG), cortical mapping], by delivering controlled electrical impulses to a specific body site for the measurement of a neural response. It may be in the form of a needle probe or surgical forceps which is attached to an electrical pulse generator. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | NVPTKITDCSWF5 | HIBCC | 5 | In Commercial Distribution | ||
| Primary | B006NVPTKITDCSWF52 | HIBCC | ||||
| Unit of Use | B006NVPTKITDCSWF5 | HIBCC |