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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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USBCAM KIT (CAMERA; HOLDER; 25 SHEATHS; DRIVER CD)
SIRONA DENTAL, INC.
B6303000
In Commercial Distribution

  • D764B63030001 ()


  • Diagnostic-imaging photographic film, self-developing
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
MONO STAN RF FORCEPS W CABLE & VIDEO CD
Cynosure, LLC
MJ11
In Commercial Distribution

  • 00841494104009 ()
MJ11

  • Open-surgery electrosurgical handpiece/electrode, bipolar, reusable
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
STABILITY/QC CONTROL MENU CD, Cutoff 150%, 50mL
BIOCHEMICAL DIAGNOSTICS INC
18008793
In Commercial Distribution

  • 00810042684447 ()
18008793

  • Multiple drugs of abuse IVD, control
STABILITY/QC CONTROL MENU CD, Cutoff -50%, 50mL
BIOCHEMICAL DIAGNOSTICS INC
18008792
In Commercial Distribution

  • 00810042684430 ()
18008792

  • Multiple drugs of abuse IVD, control
Boss Babe Body Bulk Tampons - 500 CD Regular
AL-BAD MASSUOT YITZHAK LTD
BBURBK500
In Commercial Distribution

  • 07290016625530 ()
  • 07290016625189 ()

  • Absorbency


  • Menstrual tampon, unscented
Boss Babe Body Bulk Tampons - 500 CD Super
AL-BAD MASSUOT YITZHAK LTD
BBUSBK500
In Commercial Distribution

  • 07290016625547 ()
  • 07290016625196 ()

  • Absorbency


  • Menstrual tampon, unscented
StemTrol Control Cells
Beckman Coulter, Inc.
IM3632US
In Commercial Distribution

  • 15099590762896 ()
IM3632US

  • Fixative, Orth's solution
  • Multiple CD cell marker IVD, control
It is used to scan axial length with the ultrasonic measurement function which equipped with the ECHOSCAN US-500.
NIDEK CO.,LTD.
14611-0006
In Commercial Distribution

  • 04987669200117 ()


  • Ophthalmic ultrasound imaging system
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