Gauze, External (with Drug/biologic/animal Source Material)

Device Code: 5921

Product Code(s): GER

Device Classification Information

Device Type ID5921
Device NameGauze, External (with Drug/biologic/animal Source Material)
Review PanelGeneral & Plastic Surgery
Premarket Review Office Of Device Evaluation (ODE)
Division Of Surgical Devices (DSD)
General Surgery Devices Branch One - Light Based/Laser (GSDB1)
Submission Type510(k)
FDA Device ClassificationClass Unclassified Medical Device
Product CodeGER
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5921
DeviceGauze, External (with Drug/biologic/animal Source Material)
Product CodeGER
TPLC Last Update: 2019-04-02 21:14:32

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