Cone, Radiographic, Lead-lined

Device Code: 5254

Product Code(s): EAH

Device Classification Information

Device Type ID5254
Device NameCone, Radiographic, Lead-lined
Regulation DescriptionLead-lined Position Indicator.
Regulation Medical SpecialtyDental
Review PanelRadiology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(K) Exempt
CFR Regulation Number872.1850 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeEAH
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5254
DeviceCone, Radiographic, Lead-lined
Product CodeEAH
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionLead-lined Position Indicator.
CFR Regulation Number872.1850 [🔎]
TPLC Last Update: 2019-04-02 21:03:05

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