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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 - 00847865002455

EBV IgM Assay Protocol File CD, SW4_v2
BIO-RAD LABORATORIES, INC.
6651370C
In Commercial Distribution

  • 00847865002455 ()

  • 1 Each
6651370C

  • Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay

BioPlex 2200 - 00847865002264

MMRV IgG Assay Protocol File CD, SW4_v2
BIO-RAD LABORATORIES, INC.
SW4_V2
In Commercial Distribution

  • 00847865002264 ()

  • 1 Each
6652470C

  • Measles virus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
  • Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
  • Rubella virus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
  • Mumps virus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

BioPlex 2200 - 00847865002233

Syphilis IgG Assay Protocol File CD, SW4_v2
BIO-RAD LABORATORIES, INC.
SW4_V2
In Commercial Distribution

  • 00847865002233 ()

  • 1 Each
6651470D

  • Treponema pallidum immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

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

BioPlex 2200 - 00847865001236

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

  • 00847865001236 ()

  • 1 Each
6651370D

  • Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay

HIGH DEFINITION LCD MONITOR - 04953170363498

"OEV-262H HIGH DEFINITION LED L CD MONITO"
OLYMPUS MEDICAL SYSTEMS CORP.
OEV262H
In Commercial Distribution

  • 04953170363498 ()


  • Image display unit, colour

Medtronic Reusable Instruments - 00673978062389

INSTRUMENT 85626 CD RED PED PRCSS ELVTR
MEDTRONIC SOFAMOR DANEK, INC.
85626
In Commercial Distribution

  • 00673978062389 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

Medtronic Reusable Instruments - 00673978062372

INSTRUMENT 85621 CD RED TRNS PRCSS ELVTR
MEDTRONIC SOFAMOR DANEK, INC.
85621
In Commercial Distribution

  • 00673978062372 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

Medtronic Reusable Instruments - 00673978062297

INSTRUMENT 85601 CD STRAIGHT RED HK HLDR
MEDTRONIC SOFAMOR DANEK, INC.
85601
In Commercial Distribution

  • 00673978062297 ()


  • General-purpose surgical scissors, reusable

Medtronic Reusable Instruments - 00673978058238

INSTRUMENT 84659 CD ILIO SAC SCRWDR CAN
MEDTRONIC SOFAMOR DANEK, INC.
84659
In Commercial Distribution

  • 00673978058238 ()


  • Orthopaedic implant driver

MEDI - 00636257025888

PROFILE ARM BLACK W/O GAUNTLET C-D
MEDI MANUFACTURING, INC.
CFAMSC53
In Commercial Distribution

  • 00636257025888 ()


  • Compression bandaging kit

ARCHITECT - 00380740146672

ARCHITECT UIBC-L Conv Units e-Assay CD ROM
ABBOTT LABORATORIES
4R29-1A
In Commercial Distribution

  • 00380740146672 ()
04R291A

  • Laboratory instrument/analyser application software IVD

ARCHITECT - 00380740146689

ARCHITECT UIBC-L SI Units e-Assay CD ROM
ABBOTT LABORATORIES
4R29-3A
In Commercial Distribution

  • 00380740146689 ()
04R293A

  • Laboratory instrument/analyser application software IVD

syngo Dynamics - 04056869227047

syngo Dynamics VA20F Workplace Installer CD Label
Siemens Healthcare GmbH
10745438
In Commercial Distribution

  • 04056869227047 ()


  • Radiological PACS software

Medline Industries, Inc. - 10888277842243

FCP BIPOLAR 7" 1.5 BAY CD FM
MEDLINE INDUSTRIES, INC.
DYNJBIPLR12A
In Commercial Distribution

  • 10888277842243 ()
  • 40888277842244 ()
DYNJBIPLR12A

  • General surgical procedure kit, non-medicated, reusable

Medline Industries, Inc. - 10888277842168

FCP BIPOLAR 7 BAY UNCT CD FM
MEDLINE INDUSTRIES, INC.
DYNJBIPLR11A
In Commercial Distribution

  • 10888277842168 ()
  • 40888277842169 ()
DYNJBIPLR11A

  • General surgical procedure kit, non-medicated, reusable

Medline Industries, Inc. - 10888277841482

FCP BIPOLAR 4.5 NDL UNCT CD FM
MEDLINE INDUSTRIES, INC.
DYNJBIPLR03A
In Commercial Distribution

  • 10888277841482 ()
  • 40888277841483 ()
DYNJBIPLR03A

  • General surgical procedure kit, non-medicated, reusable

CUSTOM SOUND SUITE 4.0 - CD VERSION - ENGLISH - 09321502029599

CUSTOM SOUND SUITE 4.0 - CD VERSION - ENGLISH
COCHLEAR LIMITED
Z361240
In Commercial Distribution

  • 09321502029599 ()
Z361240

  • Audiometric/hearing device software

CUSTOM SOUND SUITE 4.1 SP3 (US) - CD - 09321502029452

CUSTOM SOUND SUITE 4.1 SP3 (US) - CD
COCHLEAR LIMITED
Z540369
In Commercial Distribution

  • 09321502029452 ()
Z540369

  • Audiometric/hearing device software

Horizon - 00382906639899

BD Horizon CD 19 (SJ25C1) BV605 ASR
Becton, Dickinson And Company
663989
In Commercial Distribution

  • 00382906639899 ()
663989

  • CD19 cell marker IVD, antibody

Horizon - 00382906639882

BD Horizon CD 16 (3G8) BV605 ASR
Becton, Dickinson And Company
663988
In Commercial Distribution

  • 00382906639882 ()
663988

  • CD16 cell marker IVD, antibody

Horizon - 00382906639837

BD Horizon CD 123 (9F5) BV421 ASR
Becton, Dickinson And Company
663983
In Commercial Distribution

  • 00382906639837 ()
663983

  • Interleukin-3 receptor (IL-3r) IVD, antibody

Horizon - 00382906639806

BD Horizon CD 33 (P67.6) BV421 ASR
Becton, Dickinson And Company
663980
In Commercial Distribution

  • 00382906639806 ()
663980

  • CD33 cell marker IVD, antibody

Horizon - 00382906639950

BD Horizon CD 138 (MI15) APC-R700 ASR
Becton, Dickinson And Company
663995
In Commercial Distribution

  • 00382906639950 ()
663995

  • CD138 cell marker IVD, antibody

Horizon - 00382906639943

BD Horizon CD 123 (9F5) APC-R700 ASR
Becton, Dickinson And Company
663994
In Commercial Distribution

  • 00382906639943 ()
663994

  • Interleukin-3 receptor (IL-3r) IVD, antibody

Horizon - 00382906639820

BD Horizon CD 117 (104D2) BV421 ASR
Becton, Dickinson And Company
663982
In Commercial Distribution

  • 00382906639820 ()
663982

  • CD117 (c-kit) cell marker IVD, antibody

Horizon - 00382906639813

BD Horizon CD 34 (8G12) BV421 ASR
Becton, Dickinson And Company
663981
In Commercial Distribution

  • 00382906639813 ()
663981

  • CD34 cell marker IVD, antibody

Horizon - 00382906639790

BD Horizon CD 22 (HIB22) BV421 ASR
Becton, Dickinson And Company
663979
In Commercial Distribution

  • 00382906639790 ()
663979

  • CD22 cell marker IVD, antibody

NA - 07630031737021

CD Ø 1.2 Core drill, left-hand cut
Institut Straumann AG
non-surgically Invasive Instruments
In Commercial Distribution

  • 07630031737021 ()

  • Outer Diameter: 1.2 Millimeter
046.783

  • Dental/maxillofacial surgical procedure kit, non-medicated, single-use

Publix - 00041415080720

FLSS 40M INTSE CLN ICY MNT CD
PUBLIX SUPER MARKETS, INC.
2T2
In Commercial Distribution

  • 00041415080720 ()


  • Dental floss

Up&Up - 00071031812528

FLSS 40M EX COMF MNT 2PK CD
TARGET CORPORATION
2B8
In Commercial Distribution

  • 00071031812528 ()
  • 80071031812524 ()
  • 10071031812525 ()


  • Dental floss

MEDLINE - 00888277677848

GLOVE, EXAM, NITRILE, PF, LF, XS, CD
MEDLINE INDUSTRIES, INC.
BCH400XS
In Commercial Distribution

  • 10888277677845 ()
  • 00888277677848 ()
  • 80888277677844 ()
BCH400XS

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial

MEDLINE - 00888277677831

GLOVE, EXAM, NITRILE, PF, LF, XL, CD
MEDLINE INDUSTRIES, INC.
BCH400XL
In Commercial Distribution

  • 10888277677838 ()
  • 00888277677831 ()
  • 80888277677837 ()
BCH400XL

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial

MEDLINE - 00888277677824

GLOVE, EXAM, NITRILE, PF, LF, S, CD
MEDLINE INDUSTRIES, INC.
BCH400S
In Commercial Distribution

  • 10888277677821 ()
  • 00888277677824 ()
  • 80888277677820 ()
BCH400S

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial

MEDLINE - 00888277677817

GLOVE, EXAM, NITRILE, PF, LF, M, CD
MEDLINE INDUSTRIES, INC.
BCH400M
In Commercial Distribution

  • 10888277677814 ()
  • 00888277677817 ()
  • 80888277677813 ()
BCH400M

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial

MEDLINE - 00888277677800

GLOVE, EXAM, NITRILE, PF, LF, L, CD
MEDLINE INDUSTRIES, INC.
BCH400L
In Commercial Distribution

  • 10888277677807 ()
  • 00888277677800 ()
  • 80888277677806 ()
BCH400L

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial

ADVANCED LIMB RECONSTRUCTION SYSTEM - 18033509855672

ADV GARCHES CD UNIT LONG EXTENDS 10CM
ORTHOFIX SRL
1
In Commercial Distribution

  • 18033509855672 ()

  • Width: 117 Millimeter
53005

  • External orthopaedic fixation system, reusable

PENNIG DYNAMIC WRIST FIXATOR - 18032568036114

PENNIG DYNAMIC WRIST FIXATOR WITH CD UNIT
ORTHOFIX SRL
1
In Commercial Distribution

  • 18032568036114 ()
37001

  • External orthopaedic fixation system, reusable

DYNAMIC AXIAL FIXATOR - 18032568030464

CD UNIT - SILICONE O-RINGS PACK OF 10
ORTHOFIX SRL
1
In Commercial Distribution

  • 18032568030464 ()
10033

  • External orthopaedic fixation system, reusable

CD HORIZON® Spinal System - 00673978054247

HOOK 84193H CD HORIZON MEDIAN SS 5.5
MEDTRONIC SOFAMOR DANEK, INC.
84193H
Not in Commercial Distribution

  • 00673978054247 ()


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

CD™ SPINAL SYSTEM - 00673978053158

CONNECTOR 84154T CD HOOK ROD SCREW TI
MEDTRONIC SOFAMOR DANEK, INC.
84154T
Not in Commercial Distribution

  • 00673978053158 ()


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

CD HORIZON® Spinal System - 00885074169019

BONE SCREW 76945540 CD LGCY MS 5.5X40MM
MEDTRONIC SOFAMOR DANEK, INC.
76945540
In Commercial Distribution

  • 00885074169019 ()


  • Spinal bone screw, non-bioabsorbable

CD HORIZON® Spinal System - 00885074168999

BONE SCREW 76945530 CD LGCY MS 5.5X30MM
MEDTRONIC SOFAMOR DANEK, INC.
76945530
In Commercial Distribution

  • 00885074168999 ()


  • Spinal bone screw, non-bioabsorbable

CD HORIZON® Spinal System - 00885074168838

BONE SCREW 76944535 CD LGCY MS 4.5X35MM
MEDTRONIC SOFAMOR DANEK, INC.
76944535
In Commercial Distribution

  • 00885074168838 ()

  • Length: 35.0 Millimeter
  • Outer Diameter: 4.5 Millimeter


  • Spinal bone screw, non-bioabsorbable

Welch Allyn, Inc. - 00732094050615

ASSY CD ROM & COVER CPWS WEBSTATION 1.0
WELCH ALLYN, INC.
901047
In Commercial Distribution

  • 00732094050615 ()
404091

  • Ophthalmic/otologic diagnostic set

CD HORIZON® Spinal System - 00885074168890

BONE SCREW 76945045 CD LGCY MS 5.0X45MM
MEDTRONIC SOFAMOR DANEK, INC.
76945045
Not in Commercial Distribution

  • 00885074168890 ()

  • Length: 45.0 Millimeter
  • Outer Diameter: 5.0 Millimeter


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

CD HORIZON® Spinal System - 00885074168883

BONE SCREW 76945040 CD LGCY MS 5.0X40MM
MEDTRONIC SOFAMOR DANEK, INC.
76945040
Not in Commercial Distribution

  • 00885074168883 ()

  • Length: 40.0 Millimeter
  • Outer Diameter: 5.0 Millimeter


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

CD HORIZON® Spinal System - 00885074168876

BONE SCREW 76945035 CD LGCY MS 5.0X35MM
MEDTRONIC SOFAMOR DANEK, INC.
76945035
Not in Commercial Distribution

  • 00885074168876 ()

  • Outer Diameter: 5.0 Millimeter
  • Length: 35.0 Millimeter


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

CD HORIZON® Spinal System - 00885074168869

BONE SCREW 76945030 CD LGCY MS 5.0X30MM
MEDTRONIC SOFAMOR DANEK, INC.
76945030
Not in Commercial Distribution

  • 00885074168869 ()

  • Length: 30.0 Millimeter
  • Outer Diameter: 5.0 Millimeter


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