Primary Device ID | 00883205019738 |
NIH Device Record Key | 8103dbec-6d71-4eaf-bdba-11cbffb6468e |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | New Customer Welcome |
Version Model Number | S2931- |
Catalog Number | S2931- |
Company DUNS | 013369913 |
Company Name | ULTRADENT PRODUCTS, INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | true |
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 | true |
OTC Over-The-Counter | false |
Phone | +1(801)572-4200 |
customerservice@ultradent.com |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00883205019738 [Primary] |
EBC | SEALANT, PIT AND FISSURE, AND CONDITIONER |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2018-10-02 |
Device Publish Date | 2018-09-01 |
00883205042873 - Valo X | 2025-08-22 VALO X Red |
00883205042880 - Valo X | 2025-08-22 VALO X Pink |
00883205042897 - Valo X | 2025-08-22 VALO X Grey |
00883205042903 - Valo X | 2025-08-22 VALO X Green |
00883205042910 - Valo X | 2025-08-22 VALO X Blue |
00883205042927 - Valo X | 2025-08-22 VALO X Purple |
00883205042934 - Valo X | 2025-08-22 VALO X Black |
00883205043269 - Valo X | 2025-08-22 VALO X Loaner Unit Red |