MMS · Lubricant, Vaginal, Patient
General Hospital · 21 CFR 880.6375 · Class 1
Overview
| Product Code | MMS |
|---|---|
| Device Name | Lubricant, Vaginal, Patient |
| Regulation | 21 CFR 880.6375 |
| Device Class | Class 1 |
| Review Panel | General Hospital |
| 3rd-Party Reviewable | Yes |
Identification
A patient lubricant is a device intended for medical purposes that is used to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device.
Classification Rationale
Class I (general controls). Except when the device is a vaginal patient lubricant or an oral lubricant, it is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
