MICROTECH Summit i1200 BTE 13

by Starkey Laboratories Inc.

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

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

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00842318106926 UDI-DI	Date23 Sep 2016Listed	StatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: Microtech
Generic Name: Air-conduction hearing aid, behind-the-ear
Model / Ref / Catalog: Summit i1200 BTE 13, 64178-8

Primary DI / UDI-DI: 00842318106926
FDA Product Code: OSM, KLW
GMDN Term: Air-conduction hearing aid, behind-the-ear

Device Class: Class II
Regulation Number: 874.3305, 874.3400
GUDID distribution status: In Commercial Distribution

MRI Safety: MR Unsafe

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Properties

Prescription Use
Serial Number
Manufacturing Date

Other properties (11)

Sterile: No
Single Use: No
Implantable: No
Contains Latex: No
Over-the-Counter: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Premarket Exempt: No
Lot / Batch Number: No
Expiration Date: No