Duns Number:825137818
Device Description: Fiber Post Tapered Refill #1 Darby
Catalog Number
9520864
Brand Name
Darby Dental Supply, LLC
Version/Model Number
9520864
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)
-
Over the Counter (OTC)
Yes
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
dbe984c1-64c2-472e-ba93-6fe636ad142d
Public Version Date
October 01, 2018
Public Version Number
1
DI Record Publish Date
August 31, 2018
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 | 1457 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 194 |
| U | Unclassified | 2 |