| Primary Device ID | 00817610025145 |
| NIH Device Record Key | 5c0722f6-9ade-4396-bd5b-ef519cb245e8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Good Fit Implant Trays |
| Version Model Number | 817610025145 |
| Company DUNS | 080341158 |
| Company Name | GOOD FIT TECHNOLOGIES, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00817610025145 [Primary] |
| EHY | Tray, Impression, Preformed |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-05-14 |
| Device Publish Date | 2018-04-13 |
| 00817610025176 | Good Fit Implant Trays - Lower - LL |
| 00817610025169 | Good Fit Implant Trays - Lower - LM |
| 00817610025152 | Good Fit Implant Trays - Lower - ML |
| 00817610025145 | Good Fit Implant Trays - Lower - MM |
| 00817610025138 | Good Fit Implant Trays - Lower - MS |
| 00817610025121 | Good Fit Implant Trays - Lower - SS |
| 00817610025114 | Good Fit Implant Trays - Upper - LL |
| 00817610025107 | Good Fit Implant Trays - Upper - LM |
| 00817610025091 | Good Fit Implant Trays - Upper - ML |
| 00817610025084 | Good Fit Implant Trays - Upper - MM |
| 00817610025077 | Good Fit Implant Trays - Upper - MS |
| 00817610025060 | Good Fit Implant Trays - Upper - SS |