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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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Stem-Kit Reagents - 15099590762889

Stem-Kit Reagents
Beckman Coulter, Inc.
IM3630US
In Commercial Distribution

  • 15099590762889 ()
IM3630US

  • Multiple CD cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow)

U400 ImpSoft Software - B277292U400CD0

Impsoft data management & analysis software
IMPEDIMED LIMITED
2.2.0
In Commercial Distribution

  • B277292U400CD2 ()
  • B277292U400CD1 ()
  • B277292U400CD0 ()
292-U400CD

  • Bioelectrical body composition analyser

Body Composition Analysis Software - B277292DF50CD0

DF50 Body Composition Analysis Software
IMPEDIMED LIMITED
4.1.2
Not in Commercial Distribution

  • B277292DF50CD1 ()
  • B277292DF50CD0 ()
  • B277292DF50CD2 ()
292-DF50CD

  • Bioelectrical body composition analyser

Persona® - 00889024632387

No Description
Zimmer, Inc.
110046273
In Commercial Distribution

  • 00889024632387 ()

  • Size C-D
110046273

  • Device sterilization/disinfection container, reusable

Persona Tibial Protector Sz CD - 00889024584709

No Description
Zimmer, Inc.
SSI005591
In Commercial Distribution

  • 00889024584709 ()

  • Size CD
SSI005591

  • Knee tibia prosthesis trial, reusable

Persona® - 00889024579750

No Description
Zimmer, Inc.
110038058
In Commercial Distribution

  • 00889024579750 ()

  • Size C-D
110038058

  • Device sterilization/disinfection container, reusable

Persona® - 00889024579736

No Description
Zimmer, Inc.
110038056
In Commercial Distribution

  • 00889024579736 ()

  • Size C-D
110038056

  • Device sterilization/disinfection container, reusable

Persona® - 00889024579729

No Description
Zimmer, Inc.
110038055
In Commercial Distribution

  • 00889024579729 ()

  • Size C-D
110038055

  • Device sterilization/disinfection container, reusable

NexGen® - 00889024216693

No Description
Zimmer, Inc.
5978-07-13
In Commercial Distribution

  • 00889024216693 ()

  • Size C-D
00-5978-007-13

  • Orthopaedic prosthesis implantation positioning instrument, reusable

MICRO-MILL® NexGen® - 00889024216662

No Description
Zimmer, Inc.
5978-07-03
Not in Commercial Distribution

  • 00889024216662 ()

  • Sizes C-D


  • Orthopaedic prosthesis implantation positioning instrument, reusable

Persona Knee System - 00889024478695

No Description
Zimmer, Inc.
82-0156-860-11
In Commercial Distribution

  • 00889024478695 ()

  • Size C-D
82-0156-860-11

  • Orthopaedic broach

Persona® The Personalized Knee System - 00889024204829

No Description
Zimmer, Inc.
00-5908-015-20
In Commercial Distribution

  • 00889024204829 ()

  • Size C-D
00-5908-015-20

  • Device sterilization/disinfection container, reusable

NexGen® Legacy® - 00889024210011

No Description
Zimmer, Inc.
5961-30-23
In Commercial Distribution

  • 00889024210011 ()

  • Size CD
  • Height: 23 Millimeter
00-5961-030-23

  • Knee tibia prosthesis trial, reusable

NexGen® Legacy® - 00889024210004

No Description
Zimmer, Inc.
5961-30-20
In Commercial Distribution

  • 00889024210004 ()

  • Size CD
  • Height: 20 Millimeter
00-5961-030-20

  • Knee tibia prosthesis trial, reusable

NexGen® Legacy® - 00889024209992

No Description
Zimmer, Inc.
5961-30-17
In Commercial Distribution

  • 00889024209992 ()

  • Size CD
  • Height: 17 Millimeter
00-5961-030-17

  • Knee tibia prosthesis trial, reusable

NexGen® Legacy® - 00889024209985

No Description
Zimmer, Inc.
5961-30-14
In Commercial Distribution

  • 00889024209985 ()

  • Size CD
  • Height: 14 Millimeter
00-5961-030-14

  • Knee tibia prosthesis trial, reusable

NexGen® Legacy® - 00889024209978

No Description
Zimmer, Inc.
5961-30-12
In Commercial Distribution

  • 00889024209978 ()

  • Size CD
  • Height: 12 Millimeter
00-5961-030-12

  • Knee tibia prosthesis trial, reusable

NexGen® Legacy® - 00889024209961

No Description
Zimmer, Inc.
5961-30-10
In Commercial Distribution

  • 00889024209961 ()

  • Height: 10 Millimeter
  • Size CD
00-5961-030-10

  • Knee tibia prosthesis trial, reusable

NexGen® Legacy® - 00889024209954

No Description
Zimmer, Inc.
5961-30-09
In Commercial Distribution

  • 00889024209954 ()

  • Height: 9 Millimeter
  • Size CD
00-5961-030-09

  • Knee tibia prosthesis trial, reusable

NexGen® Legacy® - 00889024209862

No Description
Zimmer, Inc.
5961-22-23
In Commercial Distribution

  • 00889024209862 ()

  • Size CD
  • Height: 23 Millimeter
00-5961-022-23

  • Knee tibia prosthesis trial, reusable
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