Duns Number:692497670
Device Description: This device is intended to remove droplets scattered from the oral cavity. This equipment This device is intended to remove droplets scattered from the oral cavity. This equipment is a non-stand-alone device which has an electrically powered shutter for suction control without a suction pump.
Catalog Number
-
Brand Name
Free arm arteo-F(120V)
Version/Model Number
W128
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EBR
Product Code Name
Unit, Suction Operatory
Public Device Record Key
b4464499-5b71-426f-80b2-91e8c311ee29
Public Version Date
October 09, 2020
Public Version Number
1
DI Record Publish Date
October 01, 2020
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 | 8 |