Duns Number:480232605
Device Description: Software dedicated only to the Enbio autoclaves and created by our company. It will be a r Software dedicated only to the Enbio autoclaves and created by our company. It will be a read-only, visualization software for carried out sterilization or test cycles. This software will not be a software necessary for the proper operation of the device and may not be used by the end user at all. Also will not give the possibility of any interference in the device operating parameters and records of sterilization or tests carried out.
Catalog Number
-
Brand Name
Enbio Data Viewer
Version/Model Number
17
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FLE
Product Code Name
Sterilizer, Steam
Public Device Record Key
1c9af863-ce2d-43d6-9f4e-afd80960d2c8
Public Version Date
March 09, 2022
Public Version Number
1
DI Record Publish Date
March 01, 2022
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |