Duns Number:013369913
Device Description: UltraSeal XT plus Shade A1 Kit
Catalog Number
1286
Brand Name
UltraSeal XT
Version/Model Number
1286
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
EBC
Product Code Name
SEALANT, PIT AND FISSURE, AND CONDITIONER
Public Device Record Key
9c382f68-b255-41ab-8d69-59e9f05f08b1
Public Version Date
November 12, 2021
Public Version Number
1
DI Record Publish Date
November 04, 2021
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 | 450 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 631 |
| U | Unclassified | 18 |