| Primary Device ID | 00815878021664 |
| NIH Device Record Key | e8bc40b6-90ec-48d8-9ce5-dabf6c629f9a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SALIVA EJECTORS WHITE/WHITE (100) |
| Version Model Number | 72720635 |
| Company DUNS | 027532357 |
| Company Name | BURKHART DENTAL SUPPLY CO., THE |
| 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 | false |
| OTC Over-The-Counter | false |
| Phone | 800-562-8176 |
| customerservice@burkhartdental.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00815878021664 [Primary] |
| DYN | Mouthpiece, Saliva Ejector |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-04-19 |
| Device Publish Date | 2019-04-11 |
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