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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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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
Go Hearing - Go Ultra - Gray - BTE - WAG Online
HEARX GROUP (PTY) LTD
Go Ultra - Gray - BTE - WAG Online
In Commercial Distribution

  • 00810153660057 ()


  • Air-conduction hearing aid, behind-the-ear
Basin wrap 50"x50" 2.25m;on-line lam,1800pc/G
A PLUS INTERNATIONAL INC.
1
In Commercial Distribution

  • 80683534080555 ()
  • 00683534080559 ()
BW50050-1

  • Medical equipment/instrument drape, single-use
Basin wrap 50"x76" 2.25m;on-line lam, 1170pc/glrd
A PLUS INTERNATIONAL INC.
1
In Commercial Distribution

  • 80683534080562 ()
  • 00683534080566 ()
BW50076-1

  • Medical equipment/instrument drape, single-use
Go Hearing - Go Ultra - Gray - BTE - WAG Online - CASE
HEARX GROUP (PTY) LTD
Go Ultra - Gray - BTE - WAG Online - CASE
In Commercial Distribution

  • 10810153660054 ()
GHUS00002CA

  • Air-conduction hearing aid, behind-the-ear
HPLC Column, Online Method, 25-OH-Vitamin D3/D2 in serum/plasma
Chromsystems Instruments + Chemicals GmbH
38910
In Commercial Distribution

  • 04250317523822 ()

  • 1 pcs.
38910

  • High performance liquid chromatography analyser column IVD
Trap Column, Online Method, 25-OH-Vitamin D3/D2 in serum/plasma
Chromsystems Instruments + Chemicals GmbH
38920
In Commercial Distribution

  • 04250317523761 ()

  • 1 pcs.
38920

  • High performance liquid chromatography analyser column IVD
No Description
Roche Diagnostics GmbH
3516989190
Not in Commercial Distribution

  • 04015630997138 ()
3516989190

  • Phenytoin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry
No Description
Roche Diagnostics GmbH
3510620190
Not in Commercial Distribution

  • 04015630997060 ()
3510620190

  • Phenobarbital therapeutic drug monitoring IVD, kit, fluorescent immunoassay
No Description
Roche Diagnostics GmbH
3376222190
Not in Commercial Distribution

  • 04015630996933 ()
3376222190

  • Lidocaine therapeutic drug monitoring IVD, reagent
No Description
Roche Diagnostics GmbH
20737976122
In Commercial Distribution

  • 04015630993468 ()
20737976122

  • Barbiturate IVD, kit, chemiluminescent immunoassay
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