| Primary Device ID | 00817610023417 |
| NIH Device Record Key | 1be0f52e-7130-461f-8991-aa3cdb818099 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Good Fit Instant Custom Trays |
| Version Model Number | 817610023417 |
| 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 | 00817610023417 [Primary] |
| EHY | Tray, Impression, Preformed |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2017-01-10 |
| 00817610023424 | Good Fit Instant Custom Trays - Lower - XL |
| 00817610023417 | Good Fit Instant Custom Trays - Lower - L |
| 00817610023400 | Good Fit Instant Custom Trays - Lower - M |
| 00817610023394 | Good Fit Instant Custom Trays - Lower - S |
| 00817610023387 | Good Fit Instant Custom Trays - Upper - XL |
| 00817610023370 | Good Fit Instant Custom Trays - Upper - L |
| 00817610023363 | Good Fit Instant Custom Trays - Upper - M |
| 00817610023356 | Good Fit Instant Custom Trays - Upper - S |