Duns Number:688201036
Device Description: Locator, Root Apex
Catalog Number
-
Brand Name
Dr's Finder NEO
Version/Model Number
AL-DFA20
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
K171867,K171867
Product Code
LQY
Product Code Name
Locator, Root Apex
Public Device Record Key
91fe154b-77a9-4c85-beff-c8fa65aca4e4
Public Version Date
November 07, 2019
Public Version Number
1
DI Record Publish Date
October 30, 2019
Package DI Number
18800025400125
Quantity per Package
1
Contains DI Package
08800025400128
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 16 |
2 | A medical device with a moderate to high risk that requires special controls. | 7 |
U | Unclassified | 2 |