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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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Xltek - 00382830043533

Sandman Elite 9.3 Install CD ENU
Embla Systems Ltd
4283000
In Commercial Distribution

  • 00382830043533 ()


  • Sleep disorder interpretive software

660 - 03596010579591

CD 660IMS SOFTWARE UPGRADE VER 1.5
Smith & Nephew, Inc.
72201078
In Commercial Distribution

  • 03596010579591 ()
72201078

  • Endoscopic video imaging system

CD HORIZON® Spinal System - 20673978007643

SCREW 110300 BABY CD SELF BRKNG
MEDTRONIC SOFAMOR DANEK, INC.
110300
Not in Commercial Distribution

  • 20673978007643 ()
  • 00673978007649 ()


  • Bone-screw internal spinal fixation system, non-sterile

CD HORIZON® Spinal System - 00721902551215

4.5 X50MM CD HORIZON F.A SCRW
MEDTRONIC SOFAMOR DANEK, INC.
8574550
Not in Commercial Distribution

  • 00721902551215 ()

  • Outer Diameter: 4.5 Millimeter
  • Length: 50.0 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile

CD HORIZON® Spinal System - 00721902551208

4.5 X45MM CD HORIZON F.A SCRW
MEDTRONIC SOFAMOR DANEK, INC.
8574545
Not in Commercial Distribution

  • 00721902551208 ()

  • Outer Diameter: 4.5 Millimeter
  • Length: 45.0 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile

BioPlex 2200 - 00847865010962

Celiac IgG Assay Protocol File CD, SW4.1_v1
BIO-RAD LABORATORIES, INC.
SW4.1v1
In Commercial Distribution

  • 00847865010962 ()

  • 1 Each
6652270B

  • Multiple Coeliac disease-associated antibody IVD, kit, multiplex

BioPlex 2200 - 00847865010580

Celiac IgA Assay Protocol File CD, SW4_v1
BIO-RAD LABORATORIES, INC.
SW4_v1
In Commercial Distribution

  • 00847865010580 ()

  • 1 Each
6652370A

  • Multiple Coeliac disease-associated antibody IVD, kit, multiplex

BioPlex 2200 - 00847865010573

Celiac IgG Assay Protocol file CD, SW4_v1
BIO-RAD LABORATORIES, INC.
SW4_v1
In Commercial Distribution

  • 00847865010573 ()

  • 1 Each
6652270A

  • Multiple Coeliac disease-associated antibody IVD, kit, multiplex

BioPlex 2200 - 00847865002226

EBV IgG Assay Protocol File CD, SW4_v2
BIO-RAD LABORATORIES, INC.
SW4 V2
In Commercial Distribution

  • 00847865002226 ()

  • 1 Each
6651270C

  • Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
  • Epstein-Barr virus nuclear antigen (EBNA) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
  • Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

BioPlex 2200 - 00847865001250

Celiac IgA Assay Protocol File CD, SW4.1_v1
BIO-RAD LABORATORIES, INC.
SW4.1_v1
In Commercial Distribution

  • 00847865001250 ()

  • 1 Each
6652370B

  • Multiple Coeliac disease-associated antibody IVD, kit, multiplex
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