Duns Number:043835081
Device Description: An envelope that provides a barrier against fluid to protect PSP plates used for X-ray ima An envelope that provides a barrier against fluid to protect PSP plates used for X-ray images. They also prevent cross contamination between patients.
Catalog Number
-
Brand Name
ScanX Barrier Envelopes
Version/Model Number
G8511-0
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
PEM
Product Code Name
Dental Barriers And Sleeves
Public Device Record Key
20043016-c746-4a22-8f3b-0b6844def4d6
Public Version Date
January 20, 2020
Public Version Number
2
DI Record Publish Date
August 27, 2019
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 | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 11 |