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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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Medline Industries, Inc. - 10888277842717

FCP BIPOLAR BAYONET 8 CD FM
MEDLINE INDUSTRIES, INC.
DYNJBIPLR20A
In Commercial Distribution

  • 10888277842717 ()
  • 40888277842718 ()
DYNJBIPLR20A

  • General surgical procedure kit, non-medicated, reusable

Medline Industries, Inc. - 10888277842700

FCP BIPOLAR BAYONET 7 CD FM
MEDLINE INDUSTRIES, INC.
DYNJBIPLR19A
In Commercial Distribution

  • 10888277842700 ()
  • 40888277842701 ()
DYNJBIPLR19A

  • General surgical procedure kit, non-medicated, reusable

Medline Industries, Inc. - 10888277842144

FCP BIPOLAR 4.5 UNCTD CD FM
MEDLINE INDUSTRIES, INC.
DYNJBIPLR09A
In Commercial Distribution

  • 10888277842144 ()
  • 40888277842145 ()
DYNJBIPLR09A

  • General surgical procedure kit, non-medicated, reusable

Medline Industries, Inc. - 10888277841468

FCT BAYONET 8" .75MM CD FM
MEDLINE INDUSTRIES, INC.
DYNJBIPLR01A
In Commercial Distribution

  • 10888277841468 ()
  • 40888277841469 ()
DYNJBIPLR01A

  • General surgical procedure kit, non-medicated, reusable

Medline Industries, Inc. - 10888277804463

TAPE MEDI-STRIP 1/4X4IN 5/CD
MEDLINE INDUSTRIES, INC.
DYNJZ29750
In Commercial Distribution

  • 40888277804464 ()
  • 10888277804463 ()
DYNJZ29750

  • General surgical procedure kit, non-medicated, single-use

Medline Industries, Inc. - 10888277804456

TAPE MEDI-STRIP 1/2X4IN 3/CD
MEDLINE INDUSTRIES, INC.
DYNJZ29749
In Commercial Distribution

  • 40888277804457 ()
  • 10888277804456 ()
DYNJZ29749

  • General surgical procedure kit, non-medicated, single-use

DETECTABUSE - 00810042684423

CAL MENU CD, Cutoff 150%, 50mL
BIOCHEMICAL DIAGNOSTICS INC
18008791
In Commercial Distribution

  • 00810042684423 ()
18008791

  • Multiple drugs of abuse IVD, control

DETECTABUSE - 00810042684416

CAL MENU CD, Cutoff -50%, 50mL
BIOCHEMICAL DIAGNOSTICS INC
18008790
In Commercial Distribution

  • 00810042684416 ()
18008790

  • Multiple drugs of abuse IVD, control

Welch Allyn, Inc. - 00732094061420

CD, Service Manual Propaq CS, 24X
WELCH ALLYN, INC.
901062
In Commercial Distribution

  • 00732094061420 ()
810-1657-02

  • Electrocardiographic lead set, reusable

N/A - 00885074510484

CD 9732463 INSTALL U ITHR INAV
MEDTRONIC NAVIGATION, INC.
9732463
In Commercial Distribution

  • 00885074510484 ()


  • Orthopaedic stereotactic surgery 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

Guardian™ Connect - 00763000398330

RPL MMT-7821LNA GST4C LOCKOUT EN CD
MEDTRONIC MINIMED, INC.
MMT-7821LNA
In Commercial Distribution

  • 00763000398330 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical

Guardian ™ Link (3) - 00763000389024

STRT KIT MMT-7810NA GST3C 2.2A CD
MEDTRONIC XOMED, INC.
MMT-7810NA
In Commercial Distribution

  • 00763000389024 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical

iPro™ 2 - 00763000049492

RPL MMT-7741 IPRO2 RJ BATTERY CD
MEDTRONIC MINIMED, INC.
MMT-7741
In Commercial Distribution

  • 00763000049492 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical

Publix - 00041415090729

FLSS 40M EX COMF MNT CD
PUBLIX SUPER MARKETS, INC.
2G5
In Commercial Distribution

  • 00041415090729 ()


  • Dental floss

Nonin - 00849686072617

SenSmart Data Management software
NONIN MEDICAL, INC.
SenSmart Download Software
In Commercial Distribution

  • 00849686074796 ()
  • 00849686072617 ()


  • Medical equipment clinical data interfacing software

BioImp Body Composition Analysis Software SFB7 - B277299SFB7CD0

Bio Impedance analysis software ROW
IMPEDIMED LIMITED
5.5.0.1
In Commercial Distribution

  • B277299SFB7CD1 ()
  • B277299SFB7CD0 ()
299-SFB7CD

  • Bioelectrical body composition analyser

BioImp Body Composition Analysis Software SFB7 - B277293SFB7CD0

Bio Impedence analysis software US
IMPEDIMED LIMITED
5.5.0
In Commercial Distribution

  • B277293SFB7CD0 ()
  • B277293SFB7CD1 ()
293-SFB7CD

  • Bioelectrical body composition analyser

BioPlex 2200 - 00847865010993

HSV-1 & HSV-2 Assay Protocol File CD, SW4.1_v2
BIO-RAD LABORATORIES, INC.
SW4.1_V2
In Commercial Distribution

  • 00847865010993 ()

  • 1 Each
6653370E

  • Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

BioPlex 2200 - 00847865010979

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

  • 00847865010979 ()

  • 1 Each
6652470D

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

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 - 00847865010948

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

  • 00847865010948 ()

  • 1 Each
6651670H

  • Rubella virus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

BioPlex 2200 - 00847865010924

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

  • 00847865010924 ()

  • 1 Each
6651470E

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

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 - 00847865003186

Rubella & CMV Assay Protocol File CD, SW4_v3
BIO-RAD LABORATORIES, INC.
SW4_ V3
Not in Commercial Distribution

  • 00847865003186 ()

  • 1 Each
6653870C

  • Cytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay
  • Rubella virus immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay

BioPlex 2200 - 00847865002479

HSV-1 & HSV-2 Assay Protocol File CD, SW4_v2
BIO-RAD LABORATORIES, INC.
SW4_V2
In Commercial Distribution

  • 00847865002479 ()

  • 1 Each
6653370D

  • Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

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

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

MEDI - 00636257025888

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

  • 00636257025888 ()


  • Compression bandaging kit

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
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