ProShape Paper Points ISO 20.04

GUDID 10810138822491

Endo Direct LLC

Endodontic paper point
Primary Device ID10810138822491
NIH Device Record Key78f0bb13-bd6d-459c-9cb1-174e4ee06fac
Commercial Distribution StatusIn Commercial Distribution
Brand NameProShape Paper Points ISO 20.04
Version Model NumberPSGPF3
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
GS110810138822491 [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 Paper Points ISO 20.04]

10810138822491PSGPF3
10810138823078PSPP2004

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