Duns Number:009831413
Device Description: Quala Mask Earloop Latex Free Blue
Catalog Number
GCIBLA
Brand Name
Quala
Version/Model Number
GCIBLA
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FXX
Product Code Name
Mask, Surgical
Public Device Record Key
40417469-c177-438d-96d2-68478b2efd05
Public Version Date
June 19, 2020
Public Version Number
4
DI Record Publish Date
February 13, 2017
Package DI Number
D023GCIBLA5
Quantity per Package
500
Contains DI Package
D023GCIBLA3
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 |