Tissue Graft Of Less Than 6mm

Device Code: 1019

Product Code(s): LWZ

Device Classification Information

Device Type ID1019
Device NameTissue Graft Of Less Than 6mm
Review PanelCardiovascular
Premarket Review Office Of Device Evaluation (ODE)
Division Of Cardiovascular Devices (DCD)
Circulatory Support Devices Branch (CSDB)
Submission TypeContact ODE
FDA Device ClassificationClass 3 Medical Device
Product CodeLWZ
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID1019
DeviceTissue Graft Of Less Than 6mm
Product CodeLWZ
FDA Device ClassificationClass 3 Medical Device
TPLC Last Update: 2019-04-02 19:46:40

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