Primary Device ID | 00858290006079 |
NIH Device Record Key | 8b5a0523-22d9-4502-a60b-037e02fbda86 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | FluoriMax 2.5% NaF Varnish 12ML Bottle 5pk Mint |
Version Model Number | 630000510 |
Company DUNS | 002863526 |
Company Name | ELEVATE ORAL CARE, LLC |
Device Count | 5 |
DM Exempt | false |
Pre-market Exempt | false |
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 |
Phone | 877-866-9113 |
info@elevateoralcare.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00858290006079 [Primary] |
GS1 | 00858290006208 [Unit of Use] |
LBH | Varnish, Cavity |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2019-02-07 |
Device Publish Date | 2017-05-10 |
00858290006895 - Povi-One | 2023-10-05 Povi-One Unit Dose, .45ml, Demo 2pk |
00858290006888 - Advantage Arrest | 2023-07-31 Advantage Arrest, Convenience Kit |
00858290006871 - Allday Spray/Gel Sample Bag | 2023-05-26 Dry Mouth Spray and Gel, Mint, 1.5oz Bottle and Tube, Sample Bag |
00858290006758 - FluoriMax 2.5% NaF Varnish | 2022-11-07 FluoriMax 2.5% NaF Varnish 1 Bottle Kit Bubble Gum |
00858290006765 - FluoriMax 2.5% NaF Varnish | 2022-11-07 FluoriMax 2.5% NaF Varnish 1 Bottle Kit Mint |
00858290006772 - FluoriMax 2.5% NaF Varnish | 2022-11-07 FluoriMax 2.5% NaF Varnish 1 Bottle Kit Caramel |
00858290006789 - FluoriMax 2.5% NaF Varnish 1 Bottle Kit Unflavored | 2022-11-07 FluoriMax 2.5% NaF Varnish 1 Bottle Kit Unflavored |
00858290006796 - FluoriMax 2.5% NaF Varnish 1 Bottle Kit Cotton Candy | 2022-11-07 FluoriMax 2.5% NaF Varnish 1 Bottle Kit Cotton Candy |