Duns Number:009831413
Device Description: QUALA FORCEP 151-CRYER UNIV LOWER
Catalog Number
QF151
Brand Name
QUALA
Version/Model Number
QF151
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In ICCBBA
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EMG
Product Code Name
Forceps, Tooth Extractor, Surgical
Public Device Record Key
4fc15f77-b1a6-4cbf-8232-24beafdcc483
Public Version Date
October 03, 2022
Public Version Number
1
DI Record Publish Date
September 24, 2022
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 | 224 |
2 | A medical device with a moderate to high risk that requires special controls. | 192 |