| Primary Device ID | J0071600959001E1 |
| NIH Device Record Key | 1adcfd78-5cbb-4f8e-84d5-ba929631d52b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CONSOLE OPTIMA MCX WHITE EDU |
| Version Model Number | 1600959-001E |
| Catalog Number | 1600959-001E |
| Company DUNS | 480082080 |
| Company Name | Bien-Air Dental SA |
| 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 | +1 949-477-6050 |
| ba-usa@bienair.com | |
| Phone | +1 949-477-6050 |
| ba-usa@bienair.com | |
| Phone | +1 949-477-6050 |
| ba-usa@bienair.com | |
| Phone | +1 949-477-6050 |
| ba-usa@bienair.com | |
| Phone | +1 949-477-6050 |
| ba-usa@bienair.com | |
| Phone | +1 949-477-6050 |
| ba-usa@bienair.com | |
| Phone | +1 949-477-6050 |
| ba-usa@bienair.com | |
| Phone | +1 949-477-6050 |
| ba-usa@bienair.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | J0071600959001E1 [Primary] |
| EIA | Unit, operative dental |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[J0071600959001E1]
Moist Heat or Steam Sterilization
[J0071600959001E1]
Moist Heat or Steam Sterilization
[J0071600959001E1]
Moist Heat or Steam Sterilization
[J0071600959001E1]
Moist Heat or Steam Sterilization
[J0071600959001E1]
Moist Heat or Steam Sterilization
[J0071600959001E1]
Moist Heat or Steam Sterilization
[J0071600959001E1]
Moist Heat or Steam Sterilization
[J0071600959001E1]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-06-24 |
| Device Publish Date | 2022-06-16 |
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