| Primary Device ID | 00883205102058 |
| NIH Device Record Key | 875939f7-4461-4e63-8863-41097553799f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Peak Universal Bond |
| Version Model Number | S4551 |
| Catalog Number | S4551 |
| 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 | 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 | +1(801)572-4200 |
| customerservice@ultradent.com |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00883205102058 [Primary] |
| KLE | AGENT, TOOTH BONDING, RESIN |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-09-24 |
| Device Publish Date | 2016-09-22 |
| 00883205104281 | Peak Universal Bond Self-Etch Intro Kit |
| 00883205104274 | Peak Universal Bond 4ml Bottle, Self-Etch Kit |
| 00883205104267 | Peak Universal Bond 4ml bottle, Total Etch kit |
| 00883205104250 | Peak Universal Bond Total-Etch Intro Kit |
| 00883205104243 | Peak Universal Bond Econo Refill |
| 00883205104236 | Peak Universal Bond Refill |
| 00883205103161 | Peak Universal Bond 4ml Bottle Refill |
| 00883205102072 | Peak Universal Bond Unit Dose 50pk |
| 00883205102065 | Peak Universal Bond Sample SE |
| 00883205102058 | Peak Universal Bond Sample |
| 00883205035776 | Peak Universal Bond Unit Dose 50pk |