FDA UDI
In Commercial Distribution
🇺🇸 United States
MediMax Tech
DI: 00817325020381
·
Model: NCS-SG15 Surface Electrodes
·
MEDIMAX TECH INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- MediMax Tech
- Primary DI
- 00817325020381
- Version / Model
- NCS-SG15 Surface Electrodes
- Company Name
- MEDIMAX TECH INC.
- Labeler DUNS
- 927071162
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-19
- Public Version
- 4
- Public Version Date
- 2023-12-18
- Public Version Status
- Update
- Public Device Record Key
- 8403b388-21d1-4876-869f-9e4288f99210
Device Description
NCS-SG15: Surface EMG Electrodes, MAXNCS Trio, Cloth, 22x22mm, Hydrogel
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
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| GXY | Electrode, Cutaneous | Neurology | 882.1320 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 59692 | Neuromuscular transmission motion sensor | A device intended to be placed on the thumb and index finger of a patient to detect movements and convert them into electrical neuromuscular transmission (NMT) signals during nerve stimulation. The device, also known as a mechanosensor, is a piezoelectric sensor that functions with an NMT sensor cable and skin surface NMT electrodes to transmit electrical signals to a patient monitoring module dedicated to the monitoring of patient relaxation to determine level of neuromuscular block. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20817325020385 | GS1 | Master Case | 10 | In Commercial Distribution | |
| Package | 10817325020388 | GS1 | Inner Box | 25 | In Commercial Distribution | |
| Primary | 00817325020381 | GS1 |
Customer Contacts
- Phone
- 855-633-4629
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K153019 | 000 |