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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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No Description
STARKEY LABORATORIES, INC.
A4 GOLD WRLS BTE 13 PWRPLS
In Commercial Distribution

  • 00842318126467 ()
64501-2

  • Air-conduction hearing aid, behind-the-ear
  • Tinnitus masking application software
No Description
STARKEY LABORATORIES, INC.
MUSE I2000 BTE 13 PWRPLS
In Commercial Distribution

  • 00842318126450 ()
64501-1

  • Tinnitus masking application software
  • Air-conduction hearing aid, behind-the-ear
No Description
STARKEY LABORATORIES, INC.
AGXSM I2400 BTE 13 PWRPLS
In Commercial Distribution

  • 00842318126443 ()
64500-A

  • Tinnitus masking application software
  • Air-conduction hearing aid, behind-the-ear
No Description
STARKEY LABORATORIES, INC.
SUMMIT I2400 BTE 13 PWRPLS
In Commercial Distribution

  • 00842318126436 ()
64500-8

  • Air-conduction hearing aid, behind-the-ear
  • Tinnitus masking application software
No Description
STARKEY LABORATORIES, INC.
MUSE I2400 BTE 13 PWRPLS
In Commercial Distribution

  • 00842318126429 ()
64500-7

  • Tinnitus masking application software
  • Air-conduction hearing aid, behind-the-ear
No Description
STARKEY LABORATORIES, INC.
NOW PREMIER WRLS BTE 13 PWRPLS
In Commercial Distribution

  • 00842318126412 ()
64500-4

  • Air-conduction hearing aid, behind-the-ear
  • Tinnitus masking application software
No Description
STARKEY LABORATORIES, INC.
A4 PLATINUM WRLS BTE 13 PWRPLS
In Commercial Distribution

  • 00842318126405 ()
64500-2

  • Air-conduction hearing aid, behind-the-ear
  • Tinnitus masking application software
No Description
STARKEY LABORATORIES, INC.
MUSE I2400 BTE 13 PWRPLS
In Commercial Distribution

  • 00842318126399 ()
64500-1

  • Tinnitus masking application software
  • Air-conduction hearing aid, behind-the-ear
No Description
STARKEY LABORATORIES, INC.
AGXSM IQ 1000 BTE 13 PWRPLS
In Commercial Distribution

  • 00842318126382 ()
65138-A

  • Air-conduction hearing aid, behind-the-ear
  • Tinnitus masking application software
No Description
STARKEY LABORATORIES, INC.
SUMMIT IQ 1000 BTE 13 PWRPLS
In Commercial Distribution

  • 00842318126375 ()
65138-8

  • Air-conduction hearing aid, behind-the-ear
  • Tinnitus masking application software
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