ProShape Paper Points F3

GUDID 10810138822804

Endo Direct LLC

Endodontic paper point
Primary Device ID10810138822804
NIH Device Record Keyd753e473-ee95-4ebe-a3fe-053d4e8bb9e6
Commercial Distribution StatusIn Commercial Distribution
Brand NameProShape Paper Points F3
Version Model NumberPSPPF3
Company DUNS125216703
Company NameEndo Direct LLC
Device Count1
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS110810138822804 [Primary]

FDA Product Code

EKNPoint, Paper, Endodontic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-08-12
Device Publish Date2024-08-02

On-Brand Devices [ProShape Paper Points F3]

10810138822224SDGP55041
10810138822804PSPPF3

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.