| Primary Device ID | 00883205015471 |
| NIH Device Record Key | f5d755bc-637d-4cb9-a4d4-dd525b0c4031 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DermaDam |
| Version Model Number | 299- |
| Catalog Number | 299- |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(801)572-4200 |
| customerservice@ultradent.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00883205015471 [Primary] |
| EIE | DAM, RUBBER |
| 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 |
| 00883205015891 | DermaDam Heavy 36pk |
| 00883205015471 | DermaDam Non Latex Med 20pk |
| 00883205015457 | DermaDam Medium 36pk |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() DERMADAM 75177462 2226555 Live/Registered |
Ultradent Products, Inc. 1996-10-07 |