Duns Number:036623932
Catalog Number
-
Brand Name
Vista 1.7mm Endodontic Aspirator
Version/Model Number
804008
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
EHZ
Product Code Name
Evacuator, Oral Cavity
Public Device Record Key
1d1d2c3c-182f-4544-b343-a24a5bf983a4
Public Version Date
September 09, 2022
Public Version Number
1
DI Record Publish Date
September 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 |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 316 |
2 | A medical device with a moderate to high risk that requires special controls. | 144 |
U | Unclassified | 36 |