OHY · Class I — Low Risk (general controls) · General Hospital · 21 CFR 880.6430
Classification
FDA Product Code
OHY
Device class
Class I — Low Risk (general controls)
Regulation
21 CFR 880.6430
Review panel
HO
Medical specialty
General Hospital
Submission type
4
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
Definition
A device used to cut or crush medication to aid in consumption. The device is intended to only be used with medications that are labeled as acceptable for crushing or cutting.