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OtoClear Tip Sample 27230

by Bionix, LLC

OtoClear Tip Sample 27230 is an ear canal irrigation tip (FDA Class I; FDA product code KCP, Syringe, Ent) made by Bionix, LLC, listed in FDA GUDID since 11 Jul 2024 (UDI-DI 00714646000576), registry data as of 22 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00714646000576 UDI-DI Date11 Jul 2024ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
OtoClear Tip Sample
Generic name
Ear canal irrigation tip
Model / Ref / Catalog
27230
Primary DI / UDI-DI
00714646000576
FDA product code
KCP
GMDN term
Ear canal irrigation tip
Device class
Class I
Regulation number
874.5220
GUDID distribution status
In Commercial Distribution

Related devices

Category: Ear canal irrigation tip

Similar devices

Also classified as Ear canal irrigation tip.

Similar devices

Other devices filed under FDA product code KCP (SYRINGE, ENT).

Other devices from Bionix, LLC

See all devices from Bionix, LLC →

Properties

  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (10, all answered No)