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 Type ID | 2864 |
Device Name | Anti-stick Glass Syringe |
Physical State | Cone Shaped Version |
Technical Method | Self Injected Needle |
Target Area | Body |
Review Panel | General 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 Type | Enforcement Discretion |
FDA Device Classification | Class Not Classified Medical Device |
Product Code | PGO |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 2864 |
Device | Anti-stick Glass Syringe |
Product Code | PGO |