Duns Number:124117012
Device Description: Mixing Tips Blue/Orange 1:10 / 4:1 ratio
Catalog Number
-
Brand Name
Britedent
Version/Model Number
BSI-1141
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
MR Safe
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
f0105164-297b-496d-8e6e-9523583ff15f
Public Version Date
May 10, 2021
Public Version Number
1
DI Record Publish Date
April 30, 2021
Package DI Number
D974BSI11412
Quantity per Package
100
Contains DI Package
D974BSI11411
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 | 32 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |