RUSSIA Intro 1200 Wrls BTE 13
RUSSIA Intro 1200 Wrls BTE 13 (64178-P) is a Class II device made by Starkey Laboratories Inc., listed in FDA GUDID since 23 Sep 2016 (UDI-DI 00842318106964), registry data as of 22 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00842318106964 | Date23 Sep 2016 | StatusListed |
Official records
- AccessGUDID record 00842318106964
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Russia
- Generic name
- Air-conduction hearing aid, behind-the-ear
- Model / Ref / Catalog
- Intro 1200 Wrls BTE 13, 64178-P
- Primary DI / UDI-DI
- 00842318106964
- FDA product code
- KLW, OSM
- GMDN term
- Air-conduction hearing aid, behind-the-ear
- Device class
- Class II
- Regulation number
- 874.3400, 874.3305
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
Similar devices
Other devices filed under FDA product code KLW (Masker, tinnitus).
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- BEHIND-THE-EAR MASKING AMPLIFIER, 735S by Danavox, Inc.
- AUREX-3 by ADM TRONICS UNLTD, INC.
- MODEL#1550 MARSONA(R) TINNITUS MASKER by Marpac, Inc.
- HyperSound Tinnitus Module by Turtle Beach Corporation
- IE-ZEN (IN CLEAR SERIES HEARING AID) by Widex USA
- TINNITUS MASKERS MODEL S584 by Vican Instrument Co.
- JUMP S+ TRT, JUMP CIC TRT, JUMP S TRT, JUMP C TRT by Audifon-USA, Inc.
- TINNITUS THERAPY SYSTEM ANM T30 CR by Anm Adaptive Neuromodulation GmbH