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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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Darby Dental Supply, LLC - 00889813012925

CSR Wraps 24 x 24 (100) DARBY
DARBY DENTAL SUPPLY, LLC
9508264
In Commercial Distribution

  • 00889813012987 ()
  • 00889813012925 ()
  • 00889813012918 ()
9508264

  • Sterilization packaging, single-use

Pro Advantage - M220P0124242

Pro Advantage CSR Wrap 24 X 24
NATIONAL DISTRIBUTION & CONTRACTING, INC.
P012424
In Commercial Distribution

  • M220P0124245 ()
  • M220P0124242 ()
P012424

  • Sterilization packaging, single-use

Positioning Wedge - 00810044961089

Positioning Wedge 24" X 24" X 10.5"
GENEVA HEALTHCARE, LLC
30-231-00
In Commercial Distribution

  • 10810044961086 ()
  • 00810044961089 ()
30-231-00

  • Freestanding patient positioner, single-use

STAT PROFILE - 00385480489355

Stat Profile pHOx Ultra/CCX Blood Gas Controls Multipack L1, 2, 3 (Amps)
NOVA BIOMEDICAL CORPORATION
phox ultra/ccx
In Commercial Distribution

  • 00385480489355 ()
  • 00385489489356 ()
48935

  • Assisted reproduction centrifuge tube

STAT PROFILE - 00385480489041

Stat Profile pHOx Ultra/CCX Blood Gas Controls Auto-Cartridge 9/Day
NOVA BIOMEDICAL CORPORATION
PHOX ULTRA/CCX
In Commercial Distribution

  • 00385480489041 ()
48904

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

STAT PROFILE - 00385480489034

Stat Profile pHOx Ultra/CCX Blood Gas Controls Auto-Cartridge 6/Day
NOVA BIOMEDICAL CORPORATION
PHOX ULTRA/CCX
In Commercial Distribution

  • 00385480489034 ()
48903

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

STAT PROFILE - 00385480451505

Prime Auto QC Cartridge CCS 200 Sample
NOVA BIOMEDICAL CORPORATION
PRIME CCS
In Commercial Distribution

  • 00385480451505 ()
45150

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

STAT PROFILE - 00385480278966

STAT PROFILE pHOx PLUS/C CONTROL 1,2,3
NOVA BIOMEDICAL CORPORATION
phox plus/c
In Commercial Distribution

  • 00385480278966 ()
  • 00385489278967 ()
27896

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

STAT PROFILE - 00385480239332

STAT PROFILE PHOX/BASIC CONTROLS AUTO-CARTRIDGE,330
NOVA BIOMEDICAL CORPORATION
PHOX/BASIC
In Commercial Distribution

  • 00385480239332 ()
23933

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

STAT PROFILE - 00385480239325

STAT PROFILE PHOX/BASIC CONTROLS AUTO-CARTRIDGE,220
NOVA BIOMEDICAL CORPORATION
PHOX/BASIC
In Commercial Distribution

  • 00385480239325 ()
23932

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
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