ProShape Gutta Percha ISO 45.06

GUDID 10810138823054

Endo Direct LLC

Synthetic gutta-percha
Primary Device ID10810138823054
NIH Device Record Keye985760c-ac9c-4fec-a081-fea5821f5ba6
Commercial Distribution StatusIn Commercial Distribution
Brand NameProShape Gutta Percha ISO 45.06
Version Model NumberPSGP4506
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
GS110810138823054 [Primary]

FDA Product Code

EKMGutta-Percha

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 Gutta Percha ISO 45.06]

10810138822477PSGPF1
10810138823054PSGP4506

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