Duns Number:256880576
Device Description: Dental Barriers sleeves for Phosphor Storage Plate, Size small
Catalog Number
HE-BEH0
Brand Name
Elements by Hedy Barrier Envelopes
Version/Model Number
HE-BEH0
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
9a7f9cd1-ae93-4026-a5ce-0d8c0b9cf691
Public Version Date
July 16, 2020
Public Version Number
2
DI Record Publish Date
March 18, 2019
Package DI Number
D903HEBEH01
Quantity per Package
100
Contains DI Package
D903HEBEH0
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 |