| Primary Device ID | D956FLTRAY25 |
| NIH Device Record Key | 1dad5eeb-20dc-44c2-906a-87ff29a6a040 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Fluoride Gel Tray 25-pk |
| Version Model Number | FL-TRAY25 |
| Company DUNS | 532290720 |
| Company Name | D.S.I DENTAL SOLUTIONS LTD |
| 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 | false |
| 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D956FLTRAY25 [Primary] |
| KMT | Tray, Fluoride, Disposable |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-07-09 |
| Device Publish Date | 2024-07-01 |
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| D956FLTRAY25 - Fluoride Gel Tray 25-pk | 2024-07-09 |
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