Anti-Stick Glass Syringe
The Anti-Stick Glass Syringe is a single-use accessory device intended for use with sterile 1 mL long staked needle prefilled ISO standard glass syringes to protect healthcare professionals, patients who self-inject, and their assistants from accidental needlestick injuries. It is classified as "Not Classified" (Class N) by the FDA, meaning it has not been assigned to an established classification and requires further regulatory determination. The product code is PGO, reviewed by the General Hospital (HO) panel. This device is applicable to a wide patient range including children and adults.
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Basic Information
- Product Code
- PGO
- Device Class
- FDA not classified
- Medical Specialty
- Unknown
- Review Panel
- HO
- Submission Type
- 3
Device Characteristics
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.
Unclassified Reason
3
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.