Surgical Eye Tray

Device Code: 4414

Product Code(s): PZG

Definition: This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.

Device Classification Information

Device Type ID4414
Device NameSurgical Eye Tray
Physical StateThis Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.
Technical MethodThis Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.
Target AreaThis Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.
Regulation DescriptionManual Ophthalmic Surgical Instrument.
Regulation Medical SpecialtyOphthalmic
Review PanelOphthalmic
Premarket Review Office Of Device Evaluation (ODE)
Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED)
Diagnostic And Surgical Devices Branch (DSDB)
Submission TypeEnforcement Discretion
CFR Regulation Number886.4350 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodePZG
GMP ExemptNo
Summary MRIneligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4414
DeviceSurgical Eye Tray
Product CodePZG
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionManual Ophthalmic Surgical Instrument.
CFR Regulation Number886.4350 [🔎]
TPLC Last Update: 2019-04-02 20:48:39

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