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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SurgiCase Online
Materialise NV
SurgiCase Online
In Commercial Distribution

  • E314SURGICASEONLINE0 ()
SurgiCase Online

  • CAD/CAM software
ProPlan CMF Online
Materialise NV
ProPlan CMF Online
In Commercial Distribution

  • E314PROPLANCMFONLINE0 ()
ProPlan CMF Online

  • CAD/CAM software
STERILE MONTANA PACK
Cardinal Health 200, LLC
SEYCNCDPEB
In Commercial Distribution

  • 50887488660859 ()
  • 10887488660851 ()
SEYCNCDPEB

  • Ophthalmic surgical procedure kit, medicated, single-use
STERILE MONTANA PACK
Cardinal Health 200, LLC
SEYCNCDPEC
In Commercial Distribution

  • 50887488785828 ()
  • 10887488785820 ()
SEYCNCDPEC

  • Ophthalmic surgical procedure kit, medicated, single-use
Zimmer online management system
Materialise NV
Zimmer online management system
Not in Commercial Distribution

  • E314ZIMMERPSIOMS0 ()
Zimmer online management system

  • CAD/CAM software
Signature online management system
Materialise NV
Signature online management system
Not in Commercial Distribution

  • E314SIGNATUREOMS0 ()
Signature online management system

  • CAD/CAM software
10M - Montana Body Fluid
Certified Safety Manufacturing, Inc.
FK418-003
In Commercial Distribution

  • 00766588189031 ()
FK418-003

  • First aid kit, medicated
Montana BFK - 10 Refill
Certified Safety Manufacturing, Inc.
FKR418-001
In Commercial Distribution

  • 00766588189017 ()
FKR418-001

  • First aid kit, medicated
10PW - Montana Body Fluid
Certified Safety Manufacturing, Inc.
FK418-001
In Commercial Distribution

  • 00766588180014 ()
FK418-001

  • First aid kit, medicated
Lexie Lumen Duo Bronze - Online
HEARX GROUP (PTY) LTD
Lexie Lumen Duo Bronze
In Commercial Distribution

  • 00860003469866 ()
LLO00002BR

  • Air-conduction hearing aid, receiver-in-canal
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