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U.S. Department of Health and Human Services

Product Classification

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Device anti-stick glass syringe
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 individuals that assist self-injecting patients from accidental needle sticks. Can be used on a wide range of patients including children and adults.
Physical State Cone shaped version
Technical Method self injected needle
Target Area body
Review Panel General Hospital
Product CodePGO
Premarket Review Office of Device Evaluation (ODE)
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (DAGRID)
General Hospital Devices Branch (GHDB)
Not Classified Reason For Export Only
Submission Type Enforcement Discretion
Device Class Not Classified
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible