PRN — Pediatric Position Holder Class I
FDA product code PRN covers "Pediatric Position Holder", a Class I medical device regulated under 21 CFR 880.5680. Submissions are reviewed by the General Hospital panel.
Classification Details
- Product Code
- PRN
- Device Class
- Class I
- Regulation Number
- 880.5680
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
Definition
Device used to physically restrain a pediatric patient for a short surgical or clinical procedure such as circumcision. Not intended for prolonged positioning.