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J-1084A

by Summit Medical, LLC

J-1084A is an ear wick (FDA Class I; FDA product code KCN, Ear Wick) made by Summit Medical, LLC, listed in FDA GUDID since 13 Dec 2017 (UDI-DI 00385640033718), 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 Number00385640033718 UDI-DI Date13 Dec 2017ListedStatusListed 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  • Withdrawn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

Generic name
Ear wick, non-biodegradable
Model / reference
J-1084A
Primary DI / UDI-DI
00385640033718
FDA product code
KCN
GMDN term
Ear wick, non-biodegradable
Device class
Class I
Regulation number
874.5220
GUDID distribution status
In Commercial Distribution

Related devices

Category: Ear wick, non-biodegradable

Other devices from Summit Medical, LLC

See all devices from Summit Medical, LLC →

Properties

  • Supplied sterile
  • Single use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)