SkinPen F5SP581
SkinPen F5SP581 is a Class I device made by Bellus Medical, LLC, listed in FDA GUDID since 20 May 2026 (UDI-DI 00850060751738), registry data as of 22 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00850060751738 | Date20 May 2026 | StatusListed |
Official records
- AccessGUDID record 00850060751738
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- SkinPen
- Generic name
- Wound hydrogel dressing, non-antimicrobial
- Model / reference
- F5SP581
- Primary DI / UDI-DI
- 00850060751738
- FDA product code
- NAE
- GMDN term
- Wound hydrogel dressing, non-antimicrobial
- Device class
- Class I
- Regulation number
- 878.4022
- GUDID distribution status
- In Commercial Distribution
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Other devices filed under FDA product code NAE (Dressing, Wound, Hydrogel Without Drug And/Or Biologic).
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