Duns Number:430142798
Device Description: Digital intra oral sensor for radiographic examination and diagnosis of diseases of the te Digital intra oral sensor for radiographic examination and diagnosis of diseases of the teeth, jaw and oral structure.
Catalog Number
IS028-DL
Brand Name
Blu
Version/Model Number
Size 1
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
K200625
Product Code
MUH
Product Code Name
System, X-Ray, Extraoral Source, Digital
Public Device Record Key
5a971e00-8a03-42b7-90be-1d175f4096c0
Public Version Date
March 28, 2022
Public Version Number
3
DI Record Publish Date
September 17, 2020
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. | 16 |