Duns Number:043835081
Device Description: Single use covers that provide a barrier to prevent cross contamination between patients w Single use covers that provide a barrier to prevent cross contamination between patients when using the bite block.
Catalog Number
-
Brand Name
Provecta S-Pan Bite Block Covers
Version/Model Number
A7395
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
73884a83-5663-420e-a1da-4d9bdd2ecf4c
Public Version Date
August 17, 2018
Public Version Number
1
DI Record Publish Date
July 17, 2018
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 |