FDA UDI
In Commercial Distribution
🇺🇸 United States
Scorpion
DI: B006IDKWSF51252
·
Model: N/A
·
Neurovision Medical Products, Inc.
Product Codes
2
GMDN Terms
2
Identifiers
4
Pkg Device Count
5
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Basic Information
- Brand Name
- Scorpion
- Primary DI
- B006IDKWSF51252
- Version / Model
- N/A
- Catalog Number
- DSPI-DK-WSF512-5
- Company Name
- Neurovision Medical Products, Inc.
- Labeler DUNS
- 182057401
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2023-09-01
- Public Version
- 3
- Public Version Date
- 2025-09-09
- Public Version Status
- Update
- Public Device Record Key
- 1af9aec3-8bd0-4e19-80b3-ff6b5628b4a8
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
- Yes
- 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 |
| 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 |
| 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 | IDKWSF5125 | HIBCC | 5 | In Commercial Distribution | ||
| Unit of Use | B006IDKWSF5125 | HIBCC | ||||
| Primary | B006IDKWSF51252 | HIBCC | ||||
| Secondary | 00810155860622 | GS1 |