ProShape One Paper Points Large

GUDID 10810138822323

Endo Direct LLC

Endodontic paper point
Primary Device ID10810138822323
NIH Device Record Keyaa31dc7f-4c32-4bd2-8bea-58a73e72db1f
Commercial Distribution StatusIn Commercial Distribution
Brand NameProShape One Paper Points Large
Version Model NumberSDPP2504
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
GS110810138822323 [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 Date2023-07-24
Device Publish Date2023-07-15

On-Brand Devices [ProShape One Paper Points Large]

10810138822323SDPP2504
10810138822903PSOPPLG

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