| Primary Device ID | 00873263006856 |
| NIH Device Record Key | b53918e2-7b97-4afc-8b70-1850f5b26245 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Guideline 4000™ 5.0 |
| Version Model Number | C0224-00685 |
| Catalog Number | C0224 |
| Company DUNS | 108179458 |
| Company Name | FHC, 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 | true |
| 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(800)326-2905 |
| fhcinc@fh-co.com |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00873263006856 [Primary] |
| GZL | ELECTRODE, DEPTH |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-02-04 |
| Device Publish Date | 2019-01-02 |
| 00873263006856 | Guideline 4000(TM) 5.0 |
| 00873263006795 | MicroTargeting Guidline 4000 5.0 Software 1x |
| 00873263006757 | GL5 Notebook Computer |
| 00873263006740 | GL5 Main Processing Unit |