GUTTA PERCHA OBTURATOR 181-101

GUDID 08806383534758

GUTTA PERCHA OBTURATOR is used to root canal filing material.

DiaDent Group International

Synthetic gutta-percha
Primary Device ID08806383534758
NIH Device Record Key0dea5f64-77fe-4090-b15b-ab153a575571
Commercial Distribution StatusIn Commercial Distribution
Brand NameGUTTA PERCHA OBTURATOR
Version Model NumberMedium
Catalog Number181-101
Company DUNS687789453
Company NameDiaDent Group International
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 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

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from flammable and combustible materials and heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry and away from Sunlight
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from flammable and combustible materials and heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry and away from Sunlight
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from flammable and combustible materials and heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry and away from Sunlight
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from flammable and combustible materials and heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry and away from Sunlight
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from flammable and combustible materials and heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry and away from Sunlight
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from flammable and combustible materials and heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry and away from Sunlight
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from flammable and combustible materials and heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry and away from Sunlight
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from flammable and combustible materials and heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry and away from Sunlight
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from flammable and combustible materials and heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry and away from Sunlight
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from flammable and combustible materials and heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry and away from Sunlight
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from flammable and combustible materials and heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry and away from Sunlight
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from flammable and combustible materials and heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry and away from Sunlight
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from flammable and combustible materials and heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry and away from Sunlight
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from flammable and combustible materials and heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry and away from Sunlight
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from flammable and combustible materials and heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry and away from Sunlight
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from flammable and combustible materials and heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry and away from Sunlight

Device Identifiers

Device Issuing AgencyDevice ID
GS108806383534758 [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 Date2023-07-05
Device Publish Date2023-06-27

Devices Manufactured by DiaDent Group International

08806383534758 - GUTTA PERCHA OBTURATOR2023-07-05GUTTA PERCHA OBTURATOR is used to root canal filing material.
08806383534758 - GUTTA PERCHA OBTURATOR2023-07-05 GUTTA PERCHA OBTURATOR is used to root canal filing material.
08806383551014 - Endo Shaping Blocks2023-07-05 Clear acrylic blocks with high transparency for new technique training.
08806383565608 - DISPOSABLE TIPS2023-07-05 Disposable Tip for DiaFil Flow
08806383565615 - DISPOSABLE TIPS2023-07-05 Disposable Tips for DiaEtch
08806383565660 - DISPOSABLE TIPS2023-07-05 Disposable Tips for DiaFil Flow
08806383565677 - DISPOSABLE TIPS2023-07-05 Disposable Tips for DiaEtch
08806383576475 - GUTTA PERCHA POINTS2023-07-05 Gutta Percha Points is used to root canal filing material.
08806383576482 - GUTTA PERCHA POINTS2023-07-05 Gutta Percha Points is used to root canal filing material.

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