| Primary Device ID | 00815967020707 | 
| NIH Device Record Key | 5e165218-ac87-43f1-848e-e0ef5a600178 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Pac-Dent | 
| Version Model Number | DX-825 | 
| Company DUNS | 959077454 | 
| Company Name | PAC-DENT INTERNATIONAL INC | 
| Device Count | 20 | 
| 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 | 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 | false | 
| OTC Over-The-Counter | false | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00815967020660 [Unit of Use] | 
| GS1 | 00815967020707 [Primary] | 
| PEM | Dental Barriers And Sleeves | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | Update | 
| Device Record Status | Published | 
| Public Version Number | 2 | 
| Public Version Date | 2018-03-29 | 
| Device Publish Date | 2016-08-29 | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  PAC-DENT  88938193  not registered Live/Pending | Pac-Dent, Inc. 2020-05-28 |