Duns Number:036623932
Catalog Number
-
Brand Name
Vista 3cc Syringe w/ 27ga Irrigating Tips
Version/Model Number
316137
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
Yes
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
EIC
Product Code Name
Syringe, Periodontic, Endodontic, Irrigating
Public Device Record Key
18959e3f-633b-4d8b-af93-8565c0bb6dfd
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 |