Duns Number:942778564
Device Description: Finger Plugger Pl 25B 25MM
Catalog Number
FP25B25
Brand Name
Lexicon
Version/Model Number
FP25B25
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
Yes
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
EKR
Product Code Name
PLUGGER, ROOT CANAL, ENDODONTIC
Public Device Record Key
3ce41a07-4d21-403e-9dd6-40cfce7ad019
Public Version Date
September 08, 2022
Public Version Number
1
DI Record Publish Date
August 31, 2022
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 | 1973 |
2 | A medical device with a moderate to high risk that requires special controls. | 35 |
U | Unclassified | 16 |