Duns Number:199354556
Device Description: Fiber Post; 1.50 mm Posts; Shape - Parallel
Catalog Number
-
Brand Name
FibreKleer 4x
Version/Model Number
N83AC
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
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
ELR
Product Code Name
POST, ROOT CANAL
Public Device Record Key
9b89c79e-6fb4-4bdf-b97f-2ac48faf132b
Public Version Date
December 09, 2021
Public Version Number
3
DI Record Publish Date
August 01, 2016
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 | 98 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 595 |
| U | Unclassified | 5 |