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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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No Description
CHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTD
SK-3000A
In Commercial Distribution

  • 06973211070633 ()


  • Ophthalmic ultrasound imaging system
BioPlex 2200 HIV Ag-Ab Assay Protocol File CD SW4.3_v5
BIO-RAD LABORATORIES, INC.
4.3_v5
In Commercial Distribution

  • 03610520563939 ()

  • 1 Each
12001442

  • Laboratory instrument/analyser application software IVD
EZ™ Software CD & Data Cable for ECG Monitor
VASOMEDICAL, INC.
Model EZ
In Commercial Distribution

  • 00817980021396 ()
A13-0040

  • Electrocardiographic long-term ambulatory recording analyser application software
Soprano® 10 Livento® press Shade C-D Kit
Cendres+Métaux SA
08055074
In Commercial Distribution

  • 07640173094791 ()
08055074

  • Dental appliance fabrication material, ceramic
Task Force® Monitor software incl. customer CD (multilingual)
CNSystems Medizintechnik GmbH
V2.3
In Commercial Distribution

  • 09120073931931 ()
FHCS3043

  • General-purpose multi-parameter bedside monitor
ANA Screen with MDSS Assay Protocol File CD, SW4_v2
BIO-RAD LABORATORIES, INC.
SW4_V2
Not in Commercial Distribution

  • 00847865002448 ()

  • 1 Each
6651170C

  • Multiple antinuclear antibody (ANA) screening IVD, kit, multiplex
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 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
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 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
No Description
Zimmer, Inc.
110038053
In Commercial Distribution

  • 00889024579705 ()

  • 0 Degree, Size C-D
110038053

  • Device sterilization/disinfection container, reusable
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
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
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
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
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
No Description
Zimmer, Inc.
82-0156-859-14
In Commercial Distribution

  • 00889024472518 ()

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

  • Knee tibia prosthesis trial, reusable
No Description
Zimmer, Inc.
82-0156-859-13
In Commercial Distribution

  • 00889024472501 ()

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

  • Knee tibia prosthesis trial, reusable
No Description
Zimmer, Inc.
82-0156-859-12
In Commercial Distribution

  • 00889024472495 ()

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

  • Knee tibia prosthesis trial, reusable
No Description
Zimmer, Inc.
82-0156-859-11
In Commercial Distribution

  • 00889024472488 ()

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

  • Knee tibia prosthesis trial, reusable
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