Duns Number:030479000
Device Description: M&S DENTAL IMPRESS-RITE HP MIXING TIPS (PURPLE - 7.5MM) 48/BAG
Catalog Number
VPS-8120
Brand Name
IMPRESS-RITE HP MIXING TIPS
Version/Model Number
VPS-8120
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EID
Product Code Name
Syringe, Restorative And Impression Material
Public Device Record Key
163355be-cbf7-40e2-b08f-9fabf713626d
Public Version Date
October 15, 2019
Public Version Number
1
DI Record Publish Date
October 07, 2019
Package DI Number
10818524020544
Quantity per Package
48
Contains DI Package
00818524020547
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BAG
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 15 |
2 | A medical device with a moderate to high risk that requires special controls. | 46 |