| Primary Device ID | 00840067102909 |
| NIH Device Record Key | e8e902b5-f962-49a4-8d16-6a21a7f68354 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cadwell Guiardian |
| Version Model Number | 190313-200 |
| Company DUNS | 098554157 |
| Company Name | CADWELL INDUSTRIES, INC. |
| Device Count | 1 |
| DM Exempt | false |
| 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 | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| 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 | |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 00840067102909 [Primary] |
| PDQ | Neurosurgical nerve locator |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-03-12 |
| Device Publish Date | 2024-03-04 |
| 00840067103609 | AVX Auditory and Visual Stimulator |
| 00840067102916 | SMX-32 Direct Cortical Mapping |
| 00840067102909 | ES-10 Electrical Stimulator |
| 00840067102893 | 24-Channel Omni Amplifier |
| 00840067102886 | Base |
| 00840067102879 | Power Comm |