Duns Number:009900424
Device Description: Accessory Kit AmalgamBond®: (1-Brush Handle, 100- Disposable Brush Tips, 1-Spatula, 3-Meas Accessory Kit AmalgamBond®: (1-Brush Handle, 100- Disposable Brush Tips, 1-Spatula, 3-Measuring Spoons, 2 mixing wells)
Catalog Number
S375
Brand Name
AmalgamBond®
Version/Model Number
S375
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
KXF
Product Code Name
Applicator, Absorbent Tipped, Non-Sterile
Public Device Record Key
705d50d9-6890-4157-9f5c-250a4f3d2b5d
Public Version Date
February 17, 2020
Public Version Number
1
DI Record Publish Date
February 07, 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 | 36 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 476 |
| U | Unclassified | 19 |