Duns Number:046937930
Device Description: Freehand Ring platform ring is an autoclavable ring worn on the finger during dental proce Freehand Ring platform ring is an autoclavable ring worn on the finger during dental procedures which holds two types of disposable inserts. A foam insert used to remove debris from instrument tips during instrumentation or a well insert used to hold substances that are being applied to the oral cavity.
Catalog Number
-
Brand Name
Freehand Ring
Version/Model Number
FR403
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
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EJB
Product Code Name
Handle, Instrument, Dental
Public Device Record Key
819de15d-c26d-45be-8d8b-e7cb967a2521
Public Version Date
December 25, 2020
Public Version Number
1
DI Record Publish Date
December 17, 2020
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 | 1 |