Duns Number:256880576
Device Description: Dental Barrier Sleeves for Phosphor Storage Plates, Size Large
Catalog Number
HE-BEHO2
Brand Name
Elements by Hedy Barrier Envelopes
Version/Model Number
HE-BEHO2
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
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
9161aef4-e821-451b-ab33-41d2dadfa8af
Public Version Date
July 16, 2020
Public Version Number
2
DI Record Publish Date
March 18, 2019
Package DI Number
D903HEBEHO21
Quantity per Package
100
Contains DI Package
D903HEBEHO2
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 84 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |
| U | Unclassified | 2 |