FDA UDI
In Commercial Distribution
🇺🇸 United States
Arc Essentia
DI: 00840067102817
·
Model: 199283-000-010
·
CADWELL INDUSTRIES, INC.
Product Codes
6
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Arc Essentia
- Primary DI
- 00840067102817
- Version / Model
- 199283-000-010
- Company Name
- CADWELL INDUSTRIES, INC.
- Labeler DUNS
- 098554157
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-12-10
- Public Version
- 2
- Public Version Date
- 2022-11-28
- Public Version Status
- Update
- Public Device Record Key
- d3340dcd-1c0c-4676-9029-00d0488b5126
Device Description
ESSENTIA REMOTE INPUT CABLE, 10FT
Device Characteristics
- Single Use
- No
- 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
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GWQ | Full-montage Standard Electroencephalograph | Neurology | 882.1400 | 2 |
| OMC | Reduced- montage standard electroencephalograph | Neurology | 882.1400 | 2 |
| GWE | Stimulator, photic, evoked response | Neurology | 882.1890 | 2 |
| OLV | Standard polysomnograph with electroencephalograph | Neurology | 882.1400 | 2 |
| GWL | AMPLIFIER, PHYSIOLOGICAL SIGNAL | Neurology | 882.1835 | 2 |
| OLT | Non-normalizing quantitative electroencephalograph software | Neurology | 882.1400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 11474 | Electromyograph | An electrically-powered unit designed for the measurement and recording of the intrinsic electrical potential of skeletal muscle for display in the form of a graph [electromyograph (EMG)], typically for diagnosis of muscle and/or nerve disorders. It is designed to receive analogue electrical signals from EMG electrodes and process/digitize these signals for viewing, either on an integrated display or for transmission to an off-the-shelf computer. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840067102817 | GS1 |
Customer Contacts
- Phone
- +1(509)735-6481
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K133355 | 000 |