FDA UDI
In Commercial Distribution
🇺🇸 United States
ADVANCE
DI: 00851221006124
·
Model: NC-S34
·
NEUROMETRIX, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- ADVANCE
- Primary DI
- 00851221006124
- Version / Model
- NC-S34
- Company Name
- NEUROMETRIX, INC.
- Labeler DUNS
- 957536014
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-07
- Public Version
- 4
- Public Version Date
- 2018-10-22
- Public Version Status
- Update
- Public Device Record Key
- 0f0faf55-03d3-4d91-b16a-c70b57b26679
Device Description
Superficial Peroneal Biosensor (Left) Individual
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
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JXE | Device, Nerve Conduction Velocity Measurement | Neurology | 882.1550 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 11425 | Electrode conductive medium | A non-sterile substance intended to be used as a medium for the efficient transmission of electrical signals between an electrode and the body, and for the reduction of the isolation properties of the skin. It is typically in the form of a gel, paste, spray or cream and is usually used in electrocardiography, defibrillation and diathermy. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10851221006121 | GS1 | Case | 6 | In Commercial Distribution | |
| Primary | 00851221006124 | GS1 |
Customer Contacts
- Phone
- 781-314-2781
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K041320 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -30 – 60 Degrees Celsius