| Primary Device ID | 10817417021101 |
| NIH Device Record Key | 5952da05-abdc-45db-a69b-a40cba7af14f |
| Commercial Distribution Discontinuation | 2032-11-02 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MIS |
| Version Model Number | AEU-6000MIS-70V |
| Catalog Number | AEU-6000MIS-70V |
| Company DUNS | 016853348 |
| Company Name | ASEPTICO, 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 | 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 | 14254873157 |
| Regulatory@aseptico.com | |
| Phone | 14254873157 |
| Regulatory@aseptico.com | |
| Phone | 14254873157 |
| Regulatory@aseptico.com | |
| Phone | 14254873157 |
| Regulatory@aseptico.com | |
| Phone | 14254873157 |
| Regulatory@aseptico.com |
| Handling Environment Temperature | Between 10 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10817417021101 [Primary] |
| EKX | Handpiece, Direct Drive, Ac-Powered |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10817417021101]
Moist Heat or Steam Sterilization
[10817417021101]
Moist Heat or Steam Sterilization
[10817417021101]
Moist Heat or Steam Sterilization
[10817417021101]
Moist Heat or Steam Sterilization
[10817417021101]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-11-16 |
| Device Publish Date | 2022-11-08 |
| 10817417021101 | Implant / Endodontic Dental Systems |
| 10817417021279 | Implant, Endo and Oral Surgery System |
| 10817417021231 | Implant, Endo and Oral Surgery System |