Cannula, Intrauterine Insemination

Device Code: 4015

Product Code(s): MFD

Device Classification Information

Device Type ID4015
Device NameCannula, Intrauterine Insemination
Regulation DescriptionCervical Cap.
Regulation Medical SpecialtyObstetrics/Gynecology
Review PanelObstetrics/Gynecology
Premarket Review Office Of Device Evaluation (ODE)
Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD)
Obstetrics And Gynecology Devices Branch (OGDB)
Submission Type510(k)
CFR Regulation Number884.5250 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeMFD
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4015
DeviceCannula, Intrauterine Insemination
Product CodeMFD
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionCervical Cap.
CFR Regulation Number884.5250 [🔎]
TPLC Last Update: 2019-04-02 20:41:41

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