Primary Device ID | 10817417021088 |
NIH Device Record Key | ead971fa-6305-4e6b-b5b6-8f003818ab09 |
Commercial Distribution Discontinuation | 2032-11-01 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | IVIS ImplantVision |
Version Model Number | AEU-6000-IVS-70V |
Catalog Number | AEU-6000-IVS-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 | 425-487-3157 |
Regulatory@aseptico.com | |
Phone | 425-487-3157 |
Regulatory@aseptico.com | |
Phone | 425-487-3157 |
Regulatory@aseptico.com | |
Phone | 425-487-3157 |
Regulatory@aseptico.com | |
Phone | 425-487-3157 |
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 | 10817417021088 [Primary] |
EKX | Handpiece, Direct Drive, Ac-Powered |
Steralize Prior To Use | true |
Device Is Sterile | false |
[10817417021088]
Moist Heat or Steam Sterilization
[10817417021088]
Moist Heat or Steam Sterilization
[10817417021088]
Moist Heat or Steam Sterilization
[10817417021088]
Moist Heat or Steam Sterilization
[10817417021088]
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 |
10817417020760 | The AEU-1000-IVS-70V Dental Implant Motor System w/ Variable-Speed Footswitch ImplantVision is a |
10817417021088 | Implant / Endodontic Dental Systems |