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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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Sterilization tray for instruments complete
Inion Oy
0
In Commercial Distribution

  • M224ACC98079 ()
ACC-9807

  • Instrument tray, reusable
Disposable Anesthesia Mask is intended to deliver anesthetic gases to patients. In addition, anesthesia masks are also used to deliver air and/or oxygen. The mask is a Non-Sterile Product.
XIAMEN COMPOWER MEDICAL TECH. CO., LTD
0#
In Commercial Distribution

  • 06946430499882 ()


  • Anaesthesia face mask, single-use
K-WIRE .062 (1.6MM) X 6" LG
MCGINLEY ORTHOPAEDIC INNOVATIONS, LLC
0
In Commercial Distribution

  • B666MCGK60620 ()
MCGK6-062

  • Orthopaedic bone pin, non-bioabsorbable
K-WIRE .062 (1.6MM) X 4" LG
MCGINLEY ORTHOPAEDIC INNOVATIONS, LLC
0
In Commercial Distribution

  • B666MCGK40620 ()
MCGK4-062

  • Orthopaedic bone pin, non-bioabsorbable
No Description
GE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLC
ABUS Workstation
In Commercial Distribution

  • 00840682100038 ()
H5014WS

  • Breast ultrasound imaging system
No Description
GE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLC
ABUS System
Not in Commercial Distribution

  • 00840682100014 ()
H5014PM

  • Breast ultrasound imaging system
Nova Max Plus Blood Glucose Monitoring System
NOVA BIOMEDICAL CORPORATION
Plus
In Commercial Distribution

  • 10385480458242 ()
  • 00385480458245 ()
  • 20385480458249 ()
45824

  • Multiple clinical chemistry analyte monitoring system IVD, home-use
StatStrip Glucose Meter With Battery and Quick Reference Guide
NOVA BIOMEDICAL CORPORATION
1.0
In Commercial Distribution

  • 10385480449936 ()
  • 00385480449939 ()
44993

  • Glucose monitoring system IVD, point-of-care
Nova Max Link with Battery and Quick Reference Guide
NOVA BIOMEDICAL CORPORATION
Link
In Commercial Distribution

  • 10385480445853 ()
  • 00385480445856 ()
  • 20385480445850 ()
44585

  • Glucose monitoring system IVD, home-use
Nova Max Plus Blood Glucose Monitoring System
NOVA BIOMEDICAL CORPORATION
Plus
In Commercial Distribution

  • 10385480434369 ()
  • 00385480434362 ()
  • 20385480434366 ()
43436

  • Multiple clinical chemistry analyte monitoring system IVD, home-use
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