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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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No Description
ARCSCAN, INC.
EyeSeal Disposable
In Commercial Distribution

  • B017ED113 ()
  • B017ED102 ()
ED1

  • Ophthalmic ultrasound imaging system
No Description
ARCSCAN, INC.
AS100
In Commercial Distribution

  • B017AS100 ()
AS100-120

  • Ophthalmic ultrasound imaging system
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
Rubella & CMV IgM Assay Protocol File CD, SW4.1_v1
BIO-RAD LABORATORIES, INC.
SW4.1_V1
Not in Commercial Distribution

  • 00847865011006 ()

  • 1 Each
6653870D

  • Cytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay
  • Rubella virus immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay
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
ToRC IgG Assay Protocol File CD, SW 4_v3
BIO-RAD LABORATORIES, INC.
SW4_V3
In Commercial Distribution

  • 00847865002240 ()

  • 1 Each
6651670G

  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
  • Rubella virus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
FCP BIPOLAR 7 1.5 BAY CT CD FM
MEDLINE INDUSTRIES, INC.
DYNJBIPLR10A
In Commercial Distribution

  • 10888277842151 ()
  • 40888277842152 ()
DYNJBIPLR10A

  • General surgical procedure kit, non-medicated, reusable
MONO STAN RF FORCEPS W CABLE & VIDEO CD
Cynosure, LLC
MJ11
In Commercial Distribution

  • 00841494104009 ()
MJ11

  • Open-surgery electrosurgical handpiece/electrode, bipolar, reusable
ARCHITECT cSystem Conv Units e-Assay CD ROM V15.0
ABBOTT LABORATORIES
8G98-18
In Commercial Distribution

  • 00380740152130 ()
08G9818

  • Laboratory instrument/analyser application software IVD
ARCHITECT cSystem SI Units e-Assay CD ROM V15.0
ABBOTT LABORATORIES
4J62-18
In Commercial Distribution

  • 00380740152147 ()
04J6218

  • Laboratory instrument/analyser application software IVD
iQ®200 Body Fluids Module (CD only)
BECKMAN COULTER IRELAND INC.
Body Fluids Module
In Commercial Distribution

  • 10837461002475 ()
800-3704

  • Laboratory instrument/analyser application software IVD
BPX Syph Total& RPR Mnl&CD SW4.3 v5
BIO-RAD LABORATORIES, INC.
SW4.3 v5.0
In Commercial Distribution

  • 03610522207992 ()

  • 1 Each
12014549

  • Treponema pallidum total antibody IVD, kit, fluorescent immunoassay
USBCAM4 KIT (CAMERA; HOLDER; 25 SHEATHS; DRIVER CD)
SIRONA DENTAL, INC.
B6306000
In Commercial Distribution

  • D764B63060001 ()


  • Diagnostic-imaging photographic film, self-developing
USBCAM KIT (CAMERA; HOLDER; 25 SHEATHS; DRIVER CD)
SIRONA DENTAL, INC.
B6303000
In Commercial Distribution

  • D764B63030001 ()


  • Diagnostic-imaging photographic film, self-developing
Sickle Knife, 7.5mm cd bld, 6 1/2"
BOSS INSTRUMENTS, LTD., INC.
90-3301
In Commercial Distribution

  • 00888515228634 ()
90-3301

  • Ear knife
CD UNIT SPACERS (1 PAIR) FOR ELBOW FIXATOR
ORTHOFIX SRL
1
In Commercial Distribution

  • 18032568030778 ()
10076

  • External orthopaedic fixation system, reusable
Boss Babe Body Bulk Tampons - 500 CD Super
AL-BAD MASSUOT YITZHAK LTD
BBUSBK500
In Commercial Distribution

  • 07290016625547 ()
  • 07290016625196 ()

  • Absorbency


  • Menstrual tampon, unscented
Boss Babe Body Bulk Tampons - 500 CD Regular
AL-BAD MASSUOT YITZHAK LTD
BBURBK500
In Commercial Distribution

  • 07290016625530 ()
  • 07290016625189 ()

  • Absorbency


  • Menstrual tampon, unscented
ADV GARCHES CD UNIT STANDARD EXTENDS 5,5 CM
ORTHOFIX SRL
1
In Commercial Distribution

  • 18033509855665 ()

  • Width: 116 Millimeter
53004

  • External orthopaedic fixation system, reusable
CD UNIT FOR MICROMETRIC SWIVELLING CLAMP FOR LRS
ORTHOFIX SRL
1
In Commercial Distribution

  • 18032568036404 ()
50112

  • External orthopaedic fixation system, reusable
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