Arc Essentia
GUDID 00840067102817
ESSENTIA REMOTE INPUT CABLE, 10FT
CADWELL INDUSTRIES, INC.
Electromyograph Electromyograph Electromyograph Electromyograph Electromyograph Electromyograph Electromyograph Electromyograph Electromyograph Electromyograph Electromyograph Electromyograph Electromyograph Electromyograph Electromyograph Electromyograph Electromyograph Electromyograph Electromyograph Electromyograph Electromyograph Electromyograph Electromyograph Electromyograph Electromyograph| Primary Device ID | 00840067102817 |
| NIH Device Record Key | d3340dcd-1c0c-4676-9029-00d0488b5126 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Arc Essentia |
| Version Model Number | 199283-000-010 |
| Company DUNS | 098554157 |
| Company Name | CADWELL INDUSTRIES, INC. |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(509)735-6481 |
| applications@cadwell.com | |
| Phone | +1(509)735-6481 |
| applications@cadwell.com | |
| Phone | +1(509)735-6481 |
| applications@cadwell.com | |
| Phone | +1(509)735-6481 |
| applications@cadwell.com | |
| Phone | +1(509)735-6481 |
| applications@cadwell.com | |
| Phone | +1(509)735-6481 |
| applications@cadwell.com | |
| Phone | +1(509)735-6481 |
| applications@cadwell.com | |
| Phone | +1(509)735-6481 |
| applications@cadwell.com | |
| Phone | +1(509)735-6481 |
| applications@cadwell.com | |
| Phone | +1(509)735-6481 |
| applications@cadwell.com | |
| Phone | +1(509)735-6481 |
| applications@cadwell.com | |
| Phone | +1(509)735-6481 |
| applications@cadwell.com | |
| Phone | +1(509)735-6481 |
| applications@cadwell.com | |
| Phone | +1(509)735-6481 |
| applications@cadwell.com | |
| Phone | +1(509)735-6481 |
| applications@cadwell.com | |
| Phone | +1(509)735-6481 |
| applications@cadwell.com | |
| Phone | +1(509)735-6481 |
| applications@cadwell.com | |
| Phone | +1(509)735-6481 |
| applications@cadwell.com | |
| Phone | +1(509)735-6481 |
| applications@cadwell.com | |
| Phone | +1(509)735-6481 |
| applications@cadwell.com | |
| Phone | +1(509)735-6481 |
| applications@cadwell.com | |
| Phone | +1(509)735-6481 |
| applications@cadwell.com | |
| Phone | +1(509)735-6481 |
| applications@cadwell.com | |
| Phone | +1(509)735-6481 |
| applications@cadwell.com | |
| Phone | +1(509)735-6481 |
| applications@cadwell.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840067102817 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K133355
FDA Product Code
| GWQ | Full-montage Standard Electroencephalograph |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-12-18 |
| Device Publish Date | 2020-12-10 |
On-Brand Devices [Arc Essentia]
| 00840067100615 | Oximeter, USB 3012LP |
| 00840067100080 | Essentia Remote Input Box |
| 00840067100066 | Arc Essentia EEG Amplifier |
| 00840067102824 | ESSENTIA REMOTE INPUT CABLE, 25FT |
| 00840067102817 | ESSENTIA REMOTE INPUT CABLE, 10FT |
Trademark Results [Arc Essentia]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ARC ESSENTIA 86060810 4909205 Live/Registered |
Cadwell Industries, Inc. 2013-09-10 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.