Holder, Syringe, Lead

Device Code: 5295

Product Code(s): IWR

Device Classification Information

Device Type ID5295
Device NameHolder, Syringe, Lead
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 CodeIWR
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5295
DeviceHolder, Syringe, Lead
Product CodeIWR
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionPersonnel Protective Shield.
CFR Regulation Number892.6500 [🔎]
TPLC Last Update: 2019-04-02 21:03:50

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.