Shield, Gonadal

Device Code: 5297

Product Code(s): IWT

Device Classification Information

Device Type ID5297
Device NameShield, Gonadal
Regulation DescriptionPersonnel Protective Shield.
Regulation Medical SpecialtyRadiology
Review PanelRadiology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(K) Exempt
CFR Regulation Number892.6500 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeIWT
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5297
DeviceShield, Gonadal
Product CodeIWT
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionPersonnel Protective Shield.
CFR Regulation Number892.6500 [🔎]
TPLC Last Update: 2019-04-02 21:03:52

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