Punch, Skull

Device Code: 3660

Product Code(s): GXJ

Device Classification Information

Device Type ID3660
Device NamePunch, Skull
Regulation DescriptionSkull Punch.
Regulation Medical SpecialtyNeurology
Review PanelNeurology
Premarket Review Office Of Device Evaluation (ODE)
Division Of Neurological And Physical Medicine Devices (DNPMD)
Neurodiagnostic And Neurosurgical Devices Branch (NDNB)
Submission Type510(K) Exempt
CFR Regulation Number882.4750 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeGXJ
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID3660
DevicePunch, Skull
Product CodeGXJ
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionSkull Punch.
CFR Regulation Number882.4750 [🔎]
Device Problems
Break
3
Fracture
1
Device Operates Differently Than Expected
1
Total Device Problems 5
TPLC Last Update: 2019-04-02 20:33:59

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