| Primary Device ID | D691550005200 |
| NIH Device Record Key | 515ec70d-b826-46d3-add4-77818b9df2f3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AeroPro Cordless Prophy System |
| Version Model Number | AP-18-PDPC |
| Catalog Number | 5500520 |
| Company DUNS | 014789663 |
| Company Name | PREMIER DENTAL PRODUCTS COMPANY |
| 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 | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| 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 | 610-239-6000 |
| info@premierdentalco.com |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D691550005200 [Primary] |
| EKX | Handpiece, Direct Drive, Ac-Powered |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[D691550005200]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-03-18 |
| Device Publish Date | 2020-03-10 |
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