Duns Number:079212068
Device Description: OralID is intended to be used by a dentist or physician as an adjunct to an oral examinati OralID is intended to be used by a dentist or physician as an adjunct to an oral examination to aid in visualization of oral mucosal abnormalities, such as oral cancer and pre-cancer.
Catalog Number
-
Brand Name
OralID
Version/Model Number
FS-11
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
-
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
K123169
Product Code
NXV
Product Code Name
Diagnostic Light, Soft Tissue Detector
Public Device Record Key
0632d2a9-8e31-46a7-9f2b-ca42f1e165f9
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 03, 2016
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |
| U | Unclassified | 3 |