Duns Number:645717646
Device Description: Endodontic Explorer #DG 16
Catalog Number
704-996
Brand Name
Pomee
Version/Model Number
704-996
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"
-
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
EIX
Product Code Name
Probe, Periodontic
Public Device Record Key
d39841ce-6842-4bdf-be98-901185b50a94
Public Version Date
January 06, 2022
Public Version Number
1
DI Record Publish Date
December 29, 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 | 616 |