Duns Number:051194887
Device Description: Universal Workstation w/ Bien Air MX2 Electric Motor & Controller
Catalog Number
D1A3
Brand Name
n/a
Version/Model Number
D1A3
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K132315
Product Code
EIA
Product Code Name
Unit, Operative Dental
Public Device Record Key
1d00acee-7812-4aea-b8ed-6f2bb5a9d3dc
Public Version Date
October 24, 2022
Public Version Number
2
DI Record Publish Date
August 18, 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 |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 25 |