Duns Number:102422578
Device Description: Single-use barrier sleeve for use with the Ascent PX Dental Curing Light.
Catalog Number
-
Brand Name
Ascent PX Barrier Sleeve
Version/Model Number
02152
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
EBZ
Product Code Name
Activator, Ultraviolet, For Polymerization
Public Device Record Key
f0b3dbbb-9bef-4751-a177-08dcddeaa846
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
November 10, 2016
Package DI Number
00872320001490
Quantity per Package
250
Contains DI Package
00872320003319
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Pack
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 40 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 51 |