Duns Number:009831413
Device Description: Quala Intraoral X-ray Film QD57 Adult D Speed DBL
Catalog Number
18201-QU
Brand Name
Quala
Version/Model Number
18201-QU
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
IWZ
Product Code Name
Film, Radiographic
Public Device Record Key
bf6e325d-df9a-446b-9d51-b50f154d8797
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
April 11, 2017
Package DI Number
D02318201QU31
Quantity per Package
50
Contains DI Package
D02318201QU1
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 224 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 192 |