Definition: This Device Contains Items Given To An Individual During Their Hospital Stay.
Device Type ID | 2521 |
Device Name | Patient Personal Hygiene Kit |
Regulation Description | Manual Toothbrush. |
Regulation Medical Specialty | Dental |
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 | 510(K) Exempt |
CFR Regulation Number | 872.6855 [🔎] |
FDA Device Classification | Class 1 Medical Device |
Product Code | NSB |
GMP Exempt | Yes |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 2521 |
Device | Patient Personal Hygiene Kit |
Product Code | NSB |
FDA Device Classification | Class 1 Medical Device |
Regulation Description | Manual Toothbrush. |
CFR Regulation Number | 872.6855 [🔎] |
Device Problems | |
---|---|
Adverse Event Without Identified Device Or Use Problem | 1 |
Total Device Problems | 1 |