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Injector, Pen

FDA product code NSC · 1 cleared devices

Class 2 General Hospital
Regulation
21 CFR 880.5860
Review panel
HO
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2007-01-09 – 2007-01-09

A pen injector is a device that provides a nonelectrically-powered, mechanically-operated method of accurately injecting a dose of medicinal product from a medicinal cartridge, reservoir, or syringe through a manually-inserted single lumen hypodermic needle. The device can be used by health professionals or for self-injection by the patient.

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