| Primary Device ID | 10868401000220 |
| NIH Device Record Key | 1c0acbc2-3dc6-4188-b014-6e65429d07a5 |
| Commercial Distribution Discontinuation | 2017-09-18 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | RealityCHECKTM |
| Version Model Number | RC10KC |
| Company DUNS | 189236664 |
| Company Name | Wolfe & Associates Inc |
| Device Count | 25 |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | 855-588-3676 |
| xx@xx.xx | |
| Phone | 855-588-3676 |
| xx@xx.xx | |
| Phone | 855-588-3676 |
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| Phone | 855-588-3676 |
| xx@xx.xx | |
| Phone | 855-588-3676 |
| xx@xx.xx | |
| Phone | 855-588-3676 |
| xx@xx.xx | |
| Phone | 855-588-3676 |
| xx@xx.xx | |
| Phone | 855-588-3676 |
| xx@xx.xx | |
| Phone | 855-588-3676 |
| xx@xx.xx | |
| Phone | 855-588-3676 |
| xx@xx.xx | |
| Phone | 855-588-3676 |
| xx@xx.xx | |
| Phone | 855-588-3676 |
| xx@xx.xx | |
| Phone | 855-588-3676 |
| xx@xx.xx | |
| Phone | 855-588-3676 |
| xx@xx.xx | |
| Phone | 855-588-3676 |
| xx@xx.xx | |
| Phone | 855-588-3676 |
| xx@xx.xx | |
| Phone | 855-588-3676 |
| xx@xx.xx | |
| Phone | 855-588-3676 |
| xx@xx.xx | |
| Phone | 855-588-3676 |
| xx@xx.xx | |
| Phone | 855-588-3676 |
| xx@xx.xx | |
| Phone | 855-588-3676 |
| xx@xx.xx | |
| Phone | 855-588-3676 |
| xx@xx.xx | |
| Phone | 855-588-3676 |
| xx@xx.xx | |
| Phone | 855-588-3676 |
| xx@xx.xx | |
| Phone | 855-588-3676 |
| xx@xx.xx | |
| Phone | 855-588-3676 |
| xx@xx.xx | |
| Phone | 855-588-3676 |
| xx@xx.xx | |
| Phone | 855-588-3676 |
| xx@xx.xx | |
| Phone | 855-588-3676 |
| xx@xx.xx | |
| Phone | 855-588-3676 |
| xx@xx.xx | |
| Phone | 855-588-3676 |
| xx@xx.xx | |
| Phone | 855-588-3676 |
| xx@xx.xx | |
| Phone | 855-588-3676 |
| xx@xx.xx |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00868401000223 [Unit of Use] |
| GS1 | 10868401000220 [Primary] |
| LFG | Radioimmunoassay, Tricyclic Antidepressant Drugs |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2021-01-27 |
| Device Publish Date | 2016-09-24 |
| 10868401000244 | RC12KC |
| 10868401000237 | RC05AC |
| 10868401000220 | RC10KC |
| 10868401000213 | RC05ACA |
| 10868401000206 | RC05AF |