Primary Device ID | 00883205015440 |
NIH Device Record Key | d44c40be-6aa6-467d-9068-cfb08e0a7b89 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Syringe Cover |
Version Model Number | 249 |
Catalog Number | 249 |
Company DUNS | 013369913 |
Company Name | ULTRADENT PRODUCTS, INC. |
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 | false |
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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00883205015440 [Primary] |
NPK | Barrier, synthetic, intraoral |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-11-22 |
Device Publish Date | 2018-04-28 |
00883205031983 - ExperTemp | 2025-09-01 ExperTemp A2 kit |
00883205031990 - ExperTemp | 2025-09-01 ExperTemp A1 kit |
00883205032003 - ExperTemp | 2025-09-01 ExperTemp A3.5 Kit |
00883205032010 - ExperTemp | 2025-09-01 ExperTemp B1 kit |
00883205032027 - ExperTemp | 2025-09-01 ExperTemp Bleach White kit |
00883205032041 - ExperTemp | 2025-09-01 ExperTemp Mixing Tip Refill 45pk |
00883205032058 - ExperTemp | 2025-09-01 ExperTemp A3 kit |
00883205033000 - Enamelast | 2025-09-01 Sample Enamelast Walterberry |