Primary Device ID | 00817610025121 |
NIH Device Record Key | 4fb11c5b-8b57-460b-b508-a3047e18f834 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Good Fit Implant Trays |
Version Model Number | 817610025121 |
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 | 00817610025121 [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 |