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OtoClear SprayWash System, Single Use Sample 27291

by Bionix, LLC

OtoClear SprayWash System, Single Use Sample 27291, an ear canal irrigation kit (FDA Class I; FDA product code LRD, Applicator, Ent Drug) made by Bionix, LLC, was listed in FDA GUDID on 11 Jul 2024 (UDI-DI 00714646000736); the registry lists it as not in commercial distribution (GUDID) as of 22 Oct 2026.

Listed FDA GUDID listing, not in commercial distribution

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 Number00714646000736 UDI-DI Date11 Jul 2024ListedStatusListed GUDID: not 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  • Withdrawn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 SprayWash System, Single Use Sample
Generic name
Ear canal irrigation kit, reusable
Model / Ref / Catalog
27291
Primary DI / UDI-DI
00714646000736
FDA product code
LRD
GMDN term
Ear canal irrigation kit, reusable
Device class
Class I
Regulation number
874.5220
GUDID distribution status
Not in Commercial Distribution

Similar devices

Other devices filed under FDA product code LRD (APPLICATOR, ENT DRUG).

Other devices from Bionix, LLC

See all devices from Bionix, LLC →

Properties

  • Single use
  • Prescription use
  • Convenience kit
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (9, all answered No)