FDA UDI
In Commercial Distribution
🇺🇸 United States
Retropsoas Electrode
DI: 00810135960533
·
Model: ELEC1000-10
·
NVISION BIOMEDICAL TECHNOLOGIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Retropsoas Electrode
- Primary DI
- 00810135960533
- Version / Model
- ELEC1000-10
- Company Name
- NVISION BIOMEDICAL TECHNOLOGIES, INC.
- Labeler DUNS
- 047486041
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-10-25
- Public Version
- 1
- Public Version Date
- 2023-11-02
- Public Version Status
- New
- Public Device Record Key
- 7ef8819f-369e-433b-95ae-ea6d2fbf97ab
Device Description
Retropsoas Electrode, NERVE CUFF ELECTRODE, 10MM The EARP Nerve Cuff Electrode is used to perform localized stimulation of neural tissue and to locate, identify, and monitor spinal nerve roots during surgery.
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
- 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 |
|---|---|---|---|---|
| ETN | Stimulator, Nerve | Ear, Nose, Throat | 874.1820 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Primary | 00810135960533 | GS1 |
Customer Contacts
- Phone
- 210-598-5641
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K230853 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Lumen/Inner Diameter | 10 | Millimeter | |
| Height | 5 | Millimeter |