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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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Ultrasonic A/B Scanner for Ophthalmology - 06948941102213

ODM-2100 Ultrasonic A/B Scanner for Ophthalmology is an ultrasonic imaging medical device intended for ophthalmological ultrasonic diagnosis and biometric measurement.
Meda Co., Ltd
ODM-2100
In Commercial Distribution

  • 06948941102213 ()


  • Ophthalmic ultrasound imaging system

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 - 00847865002448

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

Task Force® Monitor Software - 09120073931931

Task Force® Monitor software incl. customer CD (multilingual)
CNSystems Medizintechnik GmbH
V2.3
In Commercial Distribution

  • 09120073931931 ()
FHCS3043

  • General-purpose multi-parameter bedside monitor

Soprano® 10 Livento® press - 07640173094791

Soprano® 10 Livento® press Shade C-D Kit
Cendres+Métaux SA
08055074
In Commercial Distribution

  • 07640173094791 ()
08055074

  • Dental appliance fabrication material, ceramic

BioPlex 2200 - 03610520563939

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

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

Vasomedical™ EZ™ Software CD & Data Cable for ECG Monitor - 00817980021396

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

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

Persona Knee System - 00889024472518

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

Persona Knee System - 00889024472501

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

Persona Knee System - 00889024472495

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

Persona Knee System - 00889024472488

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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