Duns Number:081305064
Device Description: MALLET MEAD1, REMOVE PLASTICS ENDS OF MALLET WHEN PUTTING INTO AUTOCLAVE. CLEAN WITH COLD MALLET MEAD1, REMOVE PLASTICS ENDS OF MALLET WHEN PUTTING INTO AUTOCLAVE. CLEAN WITH COLD STERILIZATION AND AUTOCLAVE (<120*C / 248 °F )
Catalog Number
N4223
Brand Name
Power Dental U.S.A., Inc.
Version/Model Number
N4223
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"
Yes
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
GFJ
Product Code Name
MALLET, SURGICAL, GENERAL & PLASTIC SURGERY
Public Device Record Key
f15a0e67-c888-4d15-b6c5-54c9892703cd
Public Version Date
June 28, 2021
Public Version Number
1
DI Record Publish Date
June 20, 2021
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 | 2768 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 18 |