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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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BioPlex 2200 - 00847865012331

ANA Screen with MDSS Assay Protocol File CD, SW4.1_v2
BIO-RAD LABORATORIES, INC.
SW4.1_V2
In Commercial Distribution

  • 00847865012331 ()

  • 1 Each
6651170D

  • Multiple antinuclear antibody (ANA) screening IVD, kit, multiplex

BioPlex 2200 - 03610520506462

BioPlex 2200 Lyme Total Assay Protocol File CD SW4.3_v1.0
BIO-RAD LABORATORIES, INC.
4.3_v1.0
In Commercial Distribution

  • 03610520506462 ()

  • 1 Each
12000883

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, chemiluminescent immunoassay

BioPlex 2200 - 03610520506349

25-OH Vitamin D Assay Protocol File CD, SW4.2_v3, US
BIO-RAD LABORATORIES, INC.
SW4.2 V3
In Commercial Distribution

  • 03610520506349 ()

  • 1 Each
6653775A

  • Multiple form 25-hydroxy vitamin D IVD, kit, chemiluminescent immunoassay

BioPlex 2200 - 03610520150269

BioPlex 2200 ToRC IgM Assay Protocol File CD SW4.3_v1
BIO-RAD LABORATORIES, INC.
4.3_v1
In Commercial Distribution

  • 03610520150269 ()

  • 1 Each
12000671

  • Cytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay
  • Toxoplasma gondii immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay
  • Rubella virus immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay

Persona® - 00889024579705

No Description
Zimmer, Inc.
110038053
In Commercial Distribution

  • 00889024579705 ()

  • 0 Degree, Size C-D
110038053

  • Device sterilization/disinfection container, reusable

Persona Knee System - 00889024472563

No Description
Zimmer, Inc.
82-0156-859-19
In Commercial Distribution

  • 00889024472563 ()

  • Height: 14 Millimeter
  • Femur: 3-7, Tibia: C-D
82-0156-859-19

  • Knee tibia prosthesis trial, reusable

Persona Knee System - 00889024472556

No Description
Zimmer, Inc.
82-0156-859-18
In Commercial Distribution

  • 00889024472556 ()

  • Femur: 3-7, Tibia: C-D
  • Height: 13 Millimeter
82-0156-859-18

  • Knee tibia prosthesis trial, reusable

Persona Knee System - 00889024472549

No Description
Zimmer, Inc.
82-0156-859-17
In Commercial Distribution

  • 00889024472549 ()

  • Height: 12 Millimeter
  • Femur: 3-7, Tibia: C-D
82-0156-859-17

  • Knee tibia prosthesis trial, reusable

Persona Knee System - 00889024472532

No Description
Zimmer, Inc.
82-0156-859-16
In Commercial Distribution

  • 00889024472532 ()

  • Femur: 3-7, Tibia: C-D
  • Height: 11 Millimeter
82-0156-859-16

  • Knee tibia prosthesis trial, reusable

Persona Knee System - 00889024472525

No Description
Zimmer, Inc.
82-0156-859-15
In Commercial Distribution

  • 00889024472525 ()

  • Height: 10 Millimeter
  • Femur: 3-7, Tibia: C-D
82-0156-859-15

  • Knee tibia prosthesis trial, reusable
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