Duns Number:024913248
Device Description: Indications for Use: Radiographic examination and diagnosis of diseases of the teeth, jaw Indications for Use: Radiographic examination and diagnosis of diseases of the teeth, jaw and oral structure.
Catalog Number
02HAM15302
Brand Name
InstaRay
Version/Model Number
Size 2
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
-
Product Code
MUH
Product Code Name
System, X-Ray, Extraoral Source, Digital
Public Device Record Key
24e4dc84-ddbc-4757-ae2d-4686ae26a50f
Public Version Date
January 31, 2022
Public Version Number
2
DI Record Publish Date
July 24, 2019
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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13 |