Duns Number:480232605
Device Description: Firmware dedicated only to the Enbio S autoclave and created by our company. This firmware Firmware dedicated only to the Enbio S autoclave and created by our company. This firmware does not give the possibility to the end user of any interference in the device operating parameters and records of carried out sterilization or tests.
Catalog Number
-
Brand Name
Enbio-Autoclave Control Firmware
Version/Model Number
35
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
16ca9ccd-2465-4f9d-95b4-8c8fc01aadfc
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 |