Duns Number:009831413
Device Description: Quala HP Vanilla Bite Super Fast Set
Catalog Number
Q-9004HP
Brand Name
Quala
Version/Model Number
Q-9004HP
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
-
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
ELW
Product Code Name
Material, Impression
Public Device Record Key
e0890152-5b1f-428d-ac8a-2a08e5903490
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
February 13, 2017
Package DI Number
D023Q9004HP3
Quantity per Package
10
Contains DI Package
D023Q9004HP1
Package Discontinue Date
-
Package Status
-
Package Type
Case
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 |