| Primary Device ID | 00883205028020 |
| NIH Device Record Key | b8203cfb-12ee-4d44-ba4b-fb6e67e2df4b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ultrapro Tx air |
| Version Model Number | 8502- |
| Catalog Number | 8502- |
| 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 | true |
| Manufacturing Date | true |
| 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 | +1(801)572-4200 |
| customerservice@ultradent.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00883205028020 [Primary] |
| EFB | Handpiece, air-powered, dental |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00883205028020]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-11-04 |
| Device Publish Date | 2018-07-02 |
| 00883205028082 | Ultrapro Tx Air Blue Nose Cone Kit Demo |
| 00883205028075 | Ultrapro Tx Air Motor Kit Demo |
| 00883205028068 | Ultrapro Tx Air Blue Nose Cone Kit |
| 00883205028051 | Ultrapro Tx Air Pink Nose Cone Kit |
| 00883205028044 | Ultrapro Tx Air Green Nose Cone Kit |
| 00883205028037 | Ultrapro Tx Air Motor Kit |
| 00883205028020 | Ultrapro Tx Air Kit (Prophy Handpiece Motor with 3 Nose Cones) |