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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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CD HORIZON® Spinal System - 00885074168821

BONE SCREW 76944530 CD LGCY MS 4.5X30MM
MEDTRONIC SOFAMOR DANEK, INC.
76944530
Not in Commercial Distribution

  • 00885074168821 ()

  • Length: 30.0 Millimeter
  • Outer Diameter: 4.5 Millimeter


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

CD HORIZON® Spinal System - 00885074168814

BONE SCREW 76944525 CD LGCY MS 4.5X25MM
MEDTRONIC SOFAMOR DANEK, INC.
76944525
Not in Commercial Distribution

  • 00885074168814 ()

  • Length: 25.0 Millimeter
  • Outer Diameter: 4.5 Millimeter


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

BioPlex 2200 - 00847865012607

EBV IgG Assay Protocol File CD, SW4.1_v1, US
BIO-RAD LABORATORIES, INC.
SW4.1_V1
In Commercial Distribution

  • 00847865012607 ()

  • 1 Each
6651270D

  • 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
  • Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

BioPlex 2200 - 00847865010986

BioPlex 2200 Anti-CCP Assay Protocol File CD, SW4.1_v1
BIO-RAD LABORATORIES, INC.
SW4.1_V1
In Commercial Distribution

  • 00847865010986 ()

  • 1 Each
6653270E

  • Cyclic citrullinated peptide antibody (anti-CCP) 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

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 - 00847865012508

APLS IgG, IgM and IgA Assay Protocol File CD, SW4_v1
BIO-RAD LABORATORIES, INC.
SW4_1
In Commercial Distribution

  • 00847865012508 ()

  • 1 Each
6651975A

  • Phospholipid antibody IVD, kit, multiplex

Miele - 04002515648643

Washer-Disinfector
Miele & Cie. KG
PG 8582 CD
In Commercial Distribution

  • 04002515648643 ()


  • Surgical utensil washer/disinfector

BioPlex 2200 - 00847865012973

APLS IgG, IgM and IgA Assay Protocol File CD, SW4.1_v1 US Only
BIO-RAD LABORATORIES, INC.
SW4.1V1
In Commercial Distribution

  • 00847865012973 ()

  • 1 Each
6651975B

  • Phospholipid antibody IVD, kit, multiplex

CD HORIZON Spinal System - 00643169623682

ROTATION ROD 653101500 500X5.5MM TI AL S
MEDTRONIC SOFAMOR DANEK, INC.
653101500
Not in Commercial Distribution

  • 00643169623682 ()

  • Length: 500.0 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system, sterile
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