Duns Number:716059766
Device Description: The intended medical indication is to use to hold or to fix or to remove small objects or The intended medical indication is to use to hold or to fix or to remove small objects or to bend or to cut metal strips or wire or to cut out or make dents in several places on the resin orthodontic appliance.
Catalog Number
27934
Brand Name
NA
Version/Model Number
27934
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
JEX
Product Code Name
Plier, Orthodontic
Public Device Record Key
af03cb02-4fde-4f63-9351-18ffb74284c9
Public Version Date
October 21, 2022
Public Version Number
1
DI Record Publish Date
October 13, 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 | 163 |