Anti-stick Glass Syringe

Device Code: 2864

Product Code(s): PGO

Definition: Single Use Devices That Are Indicated For Use As An Accessory With Sterile 1ML Long Staked Needle Prefilled ISO Standard Glass Syringes To Aid In The Protection Of Healthcare Professionals, Patients Who Self-inject, Doctor Prescribed Medications, And

Device Classification Information

Device Type ID2864
Device NameAnti-stick Glass Syringe
Physical StateCone Shaped Version
Technical MethodSelf Injected Needle
Target AreaBody
Review PanelGeneral Hospital
Premarket Review Office Of Device Evaluation (ODE)
Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID)
General Hospital Devices Branch (GHDB)
Submission TypeEnforcement Discretion
FDA Device ClassificationClass Not Classified Medical Device
Product CodePGO
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID2864
DeviceAnti-stick Glass Syringe
Product CodePGO
TPLC Last Update: 2019-04-02 20:20:15

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