Duns Number:316179456
Device Description: FG piranha coarse
Catalog Number
-
Brand Name
FG diamond
Version/Model Number
539085
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
DZP
Product Code Name
INSTRUMENT, DIAMOND, DENTAL
Public Device Record Key
907e3451-b1c6-4fae-b898-9e434dd6d539
Public Version Date
January 22, 2021
Public Version Number
1
DI Record Publish Date
January 14, 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 | 3171 |
2 | A medical device with a moderate to high risk that requires special controls. | 6 |