Stent, Bladder, Fetal

Device Code: 4123

Product Code(s): MPR

Device Classification Information

Device Type ID4123
Device NameStent, Bladder, Fetal
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 TypeHDE - Humanitarian Device Exem
FDA Device ClassificationClass HDE Medical Device
Product CodeMPR
GMP ExemptNo
Summary MREligible
Implanted DeviceYes
Life Support DeviceYes
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4123
DeviceStent, Bladder, Fetal
Product CodeMPR
Device Problems
Other (for Use When An Appropriate Device Code Cannot Be Identified)
1
Bent
1
Total Device Problems 2
TPLC Last Update: 2019-04-02 20:43:25

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