Needle, Isotope, Reprocessed

Device Code: 5400

Product Code(s): NMP

Device Classification Information

• Device Type ID: 5400
• Device Name: Needle, Isotope, Reprocessed
• Regulation Description: Radionuclide Brachytherapy Source.
• Regulation Medical Specialty: Radiology
• Review Panel: Radiology
• Premarket Review: Office Of In Vitro Diagnostics And Radiological Health (OIR)
• Submission Type: 510(k)
• CFR Regulation Number: 892.5730 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: NMP
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

• Device Type ID: 5400
• Device: Needle, Isotope, Reprocessed
• Product Code: NMP
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Radionuclide Brachytherapy Source.
• CFR Regulation Number: 892.5730 [🔎]

TPLC Last Update: 2019-04-02 21:05:34