NeoSEALER EZ-Flo (1.5 g syringe & 15 Tips) Starter Kit

GUDID 00810118103735

For use in obturating root canals as part of orthograde root canal therapy with gutta percha.

NUSMILE, LTD.

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Primary Device ID00810118103735
NIH Device Record Key8331d3d0-721b-4f6b-9703-3443737e8cbb
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeoSEALER EZ-Flo (1.5 g syringe & 15 Tips) Starter Kit
Version Model NumberANSEZFS
Company DUNS185497372
Company NameNUSMILE, LTD.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Dimensions

Weight2.2 Gram
Weight2.2 Gram
Weight2.2 Gram
Weight2.2 Gram
Weight2.2 Gram
Weight2.2 Gram
Weight2.2 Gram
Weight2.2 Gram
Weight2.2 Gram
Weight2.2 Gram
Weight2.2 Gram
Weight2.2 Gram
Weight2.2 Gram
Weight2.2 Gram
Weight2.2 Gram
Weight2.2 Gram
Weight2.2 Gram

Operating and Storage Conditions

Storage Environment TemperatureBetween 72 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment TemperatureBetween 72 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment TemperatureBetween 72 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment TemperatureBetween 72 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment TemperatureBetween 72 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment TemperatureBetween 72 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment TemperatureBetween 72 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment TemperatureBetween 72 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment TemperatureBetween 72 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment TemperatureBetween 72 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment TemperatureBetween 72 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment TemperatureBetween 72 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment TemperatureBetween 72 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment TemperatureBetween 72 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment TemperatureBetween 72 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment TemperatureBetween 72 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment TemperatureBetween 72 Degrees Fahrenheit and 0 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100810118103735 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-07
Device Publish Date2023-10-30

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