Biodentine Applicator (Gun) 01C0730

GUDID 03701398108510

Device for extrusion of dentine substitute.

SEPTODONT SAS SPECIALITES SEPTODONT

Dental material cartridge-plunging applicator, single-component
Primary Device ID03701398108510
NIH Device Record Keyd8ca8024-feb8-40fa-95b5-fe71c4d66777
Commercial Distribution StatusIn Commercial Distribution
Brand NameBiodentine Applicator (Gun)
Version Model Number01C0730
Catalog Number01C0730
Company DUNS275273795
Company NameSEPTODONT SAS SPECIALITES SEPTODONT
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
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
GS103701398108503 [Primary]
GS103701398108510 [Direct Marking]

FDA Product Code

EJBHandle, Instrument, Dental

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[03701398108510]

Moist Heat or Steam Sterilization


[03701398108510]

Moist Heat or Steam Sterilization


[03701398108510]

Moist Heat or Steam Sterilization


[03701398108510]

Moist Heat or Steam Sterilization


[03701398108510]

Moist Heat or Steam Sterilization


[03701398108510]

Moist Heat or Steam Sterilization


[03701398108510]

Moist Heat or Steam Sterilization


[03701398108510]

Moist Heat or Steam Sterilization


[03701398108510]

Moist Heat or Steam Sterilization


[03701398108510]

Moist Heat or Steam Sterilization


[03701398108510]

Moist Heat or Steam Sterilization


[03701398108510]

Moist Heat or Steam Sterilization


[03701398108510]

Moist Heat or Steam Sterilization


[03701398108510]

Moist Heat or Steam Sterilization


[03701398108510]

Moist Heat or Steam Sterilization


[03701398108510]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-12-09
Device Publish Date2024-12-01

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