Duns Number:083235549
Device Description: iNterra™ iNoffice Nightguard Refill Package, Medium Arch, 6
Catalog Number
61D030
Brand Name
iNterra™ iNoffice Nightguard
Version/Model Number
61D030
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EBI
Product Code Name
RESIN, DENTURE, RELINING, REPAIRING, REBASING
Public Device Record Key
d0fa12ab-d59d-4bb2-abb6-36080e1a6559
Public Version Date
September 24, 2018
Public Version Number
4
DI Record Publish Date
September 21, 2016
Package DI Number
D00261D03062
Quantity per Package
6
Contains DI Package
D00261D0301
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 | 123 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 397 |
| U | Unclassified | 2 |