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Osseous E7168-Oc

by Eon Meditech Private Limited

Osseous E7168-Oc is an ear wick (FDA Class I; FDA product code KCN, Ear Wick) made by Eon Meditech Private Limited, listed in FDA GUDID since 12 Jun 2024 (UDI-DI 08904428721597), registry data as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08904428721597 UDI-DI Date12 Jun 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  • Withdrawn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
Osseous
Generic name
Ear wick, non-biodegradable
Model / reference
E7168-OC
Primary DI / UDI-DI
08904428721597
FDA product code
KCN
GMDN term
Ear wick, non-biodegradable
Device class
Class I
Regulation number
874.5220
GUDID distribution status
In Commercial Distribution
Size
Outer Diameter — 12 Millimeter
Length — 24 Millimeter

Similar devices in this category

Other devices filed under Ear wick, non-biodegradable.

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Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Over-the-counter
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (7, all answered No)