MTA BIOREP MTA-BRP2.2

GUDID 03760260220385

ITENA CLINICAL

Hygroscopic dental cement
Primary Device ID03760260220385
NIH Device Record Keyc9a8aad6-89b1-4c64-91dc-ae8c9f373429
Commercial Distribution StatusIn Commercial Distribution
Brand NameMTA BIOREP
Version Model NumberCoffret MTA BIOREP 2 patients
Catalog NumberMTA-BRP2.2
Company DUNS278261221
Company NameITENA CLINICAL
Device Count2
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS103760260220385 [Primary]
GS103760260223508 [Unit of Use]

FDA Product Code

KIFResin, Root Canal Filling

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-12-01
Device Publish Date2022-11-23

On-Brand Devices [MTA BIOREP ]

03760260220392Coffret MTA BIOREP 5 patients
03760260220385Coffret MTA BIOREP 2 patients

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