Primary Device ID | 00817610023387 |
NIH Device Record Key | 3346b252-1a77-4343-875a-1f690a838fb1 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Good Fit Instant Custom Trays |
Version Model Number | 817610023387 |
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 | 00817610023387 [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 | 2017-06-24 |
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 |