Retractor, All Types

Device Code: 1186

Product Code(s): EIG

Device Classification Information

Device Type ID1186
Device NameRetractor, All Types
Regulation DescriptionDental Hand Instrument.
Regulation Medical SpecialtyDental
Review PanelDental
Premarket Review Office Of Device Evaluation (ODE)
Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID)
Dental Devices Branch (DEDB)
Submission Type510(K) Exempt
CFR Regulation Number872.4565 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeEIG
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID1186
DeviceRetractor, All Types
Product CodeEIG
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionDental Hand Instrument.
CFR Regulation Number872.4565 [🔎]
Device Problems
Device Markings / Labelling Problem
1
Break
1
Total Device Problems 2
TPLC Last Update: 2019-04-02 19:49:37

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