EarClear Rx 90006
EarClear Rx 90006 is a tissue specimen microdissection system IVD (FDA Class I; FDA product code KCP, Syringe, Ent) made by Nuance Medical, LLC, listed in FDA GUDID since 25 Oct 2018 (UDI-DI 00856331006217), 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 | Number00856331006217 | Date25 Oct 2018 | StatusListed |
Official records
- AccessGUDID record 00856331006217
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- EarClear Rx
- Generic name
- Tissue specimen microdissection system IVD, mechanical excision
- Model / Ref / Catalog
- 90006
- Primary DI / UDI-DI
- 00856331006217
- FDA product code
- KCP
- GMDN term
- Tissue specimen microdissection system IVD, mechanical excision
- Device class
- Class I
- Regulation number
- 874.5220
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code KCP (SYRINGE, ENT).