Injector, Jet, Gas-powered

Device Code: 1164

Product Code(s): EGQ

Device Classification Information

Device Type ID1164
Device NameInjector, Jet, Gas-powered
Regulation DescriptionGas-powered Jet Injector.
Regulation Medical SpecialtyDental
Review PanelDental
Premarket Review Office Of Device Evaluation (ODE)
Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID)
Dental Devices Branch (DEDB)
Submission Type510(k)
CFR Regulation Number872.4465 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeEGQ
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

Total Product Life Cycle

Device Type ID1164
DeviceInjector, Jet, Gas-powered
Product CodeEGQ
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionGas-powered Jet Injector.
CFR Regulation Number872.4465 [🔎]
TPLC Last Update: 2019-04-02 19:49:14

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