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Capella2 OAE Start-Up Kit 8-69-42800

by Intelligent Hearing Systems Corp.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00817020020280 UDI-DI Date9 Jun 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Capella2 OAE Start-Up Kit
Generic Name
Audiometric ear tip
Model / Reference
8-69-42800
Primary DI / UDI-DI
00817020020280
510(k) Number
FDA Product Code
EWO
GMDN Term
Audiometric ear tip
Device Class
Class II
Regulation Number
874.1050
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K061443)

Other devices from Intelligent Hearing Systems Corp.

See all devices from Intelligent Hearing Systems Corp. →

Properties

  • Single Use
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number

Other properties (10)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No