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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Lexie B1 Hearing Aids, powered by Bose. Self-fit, app-controlled hearing aids
HEARX GROUP (PTY) LTD
LB1001
In Commercial Distribution

Online

  • Air-conduction hearing aid, receiver-in-canal
Lexie Lumen Duo Metalic Black - Online
HEARX GROUP (PTY) LTD
Lexie Lumen Duo Metalic Black
In Commercial Distribution

  • 00860003469880 ()
LLO00002MB

  • Air-conduction hearing aid, receiver-in-canal
Lexie Lumen Duo Light Gray - Online
HEARX GROUP (PTY) LTD
Lexie Lumen Duo Light Gray
In Commercial Distribution

  • 00860003469842 ()
LLO00002GR

  • Air-conduction hearing aid, receiver-in-canal
Alcon Online Barrett Toric IOL Calculator
Alcon Laboratories, Inc.
Version 2
In Commercial Distribution

  • 00380659909498 ()


  • Intraocular lens calculation software
MONTANA VA C & B QUICKIT 1P
Peter Brasseler Holdings, LLC
5024937U0
In Commercial Distribution

  • 00887919737896 ()


  • Diamond dental bur, single-use
R138-25 25th Anniversary Montana Jack®
PDT, INC.
R138-25 25th Anniversary Montana Jack®
In Commercial Distribution

  • 00813677025197 ()
R138-25

  • Manual dental scaler, reusable
Lexie Lumen OTC Hearing Aids - Beige Online
HEARX GROUP (PTY) LTD
Lexie Lumen Duo Beige
In Commercial Distribution

  • 00850022464157 ()
LLO00003BE

  • Air-conduction hearing aid, receiver-in-canal
Lexie Lumen OTC Hearing Aids - Gray Online
HEARX GROUP (PTY) LTD
Lexie Lumen Duo Gray
In Commercial Distribution

  • 00850022464065 ()
LLO00001GR

  • Air-conduction hearing aid, receiver-in-canal
Lexie B2 Plus Powered by Bose-WAG Online
HEARX GROUP (PTY) LTD
Lexie Hearing
In Commercial Distribution

  • 00810153660033 ()
LBS00002B2PLS

  • Air-conduction hearing aid, receiver-in-canal
R138BCR Montana Jack® Rigid Scaler Pink
PDT, INC.
R138BCR
In Commercial Distribution

  • 00813677024350 ()


  • Manual dental scaler, reusable
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