ProShape Paper Points F5

GUDID 10810138822248

Endo Direct LLC

Endodontic paper point
Primary Device ID10810138822248
NIH Device Record Key5a97b62f-12c6-4641-bfc8-62404572c935
Commercial Distribution StatusIn Commercial Distribution
Brand NameProShape Paper Points F5
Version Model NumberSDGP20061
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
GS110810138822248 [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 Date2023-07-18
Device Publish Date2023-07-10

On-Brand Devices [ProShape Paper Points F5]

10810138822248SDGP20061
10810138822828PSPPF5

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