Duns Number:190377184
Device Description: Euro Barrier Envelopes, East-Tear, For Phosphor Plates, #4
Catalog Number
BEUR-004S
Brand Name
Plasdent
Version/Model Number
BEUR-004S
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
EGZ
Product Code Name
Holder, Film, X-Ray
Public Device Record Key
7df5a5ba-d183-45a6-a352-23bb47edaa29
Public Version Date
March 30, 2022
Public Version Number
1
DI Record Publish Date
March 22, 2022
Package DI Number
D832BEUR004S2
Quantity per Package
100
Contains DI Package
D832BEUR004S1
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 750 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 36 |