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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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Ultra Instruments Clamp; Thompson Carotid; 6 in
SYMMETRY SURGICAL INC.
55-5063
In Commercial Distribution

  • 00887482083659 ()

  • Length: 6 Inch
55-5063

  • Clamp manipulation forceps
Ultra Instruments Clamp; Heaney Subclavian; 8 in
SYMMETRY SURGICAL INC.
55-5061
In Commercial Distribution

  • 00887482083642 ()

  • Length: 8 Inch
55-5061

  • Clamp manipulation forceps
Symmetry® Clamp; Cooley Coarctation; 6 in
SYMMETRY SURGICAL INC.
55-5010
In Commercial Distribution

  • 00887482083253 ()

  • Length: 6 Inch
55-5010

  • Clamp manipulation forceps
This product is the hood for observation assistance used in combination with our endoscopes in medical facilities.
FUJIFILM CORPORATION
DH-17EN
In Commercial Distribution

  • 04547410074093 ()
  • 84547410074099 ()


  • Endoscope tissue removal cap, single-use
In vitro diagnostics medical device. For measurement of glucose in Siemens Healthcare Diagnostics RAPIDLab® Series systems.
Siemens Healthcare Diagnostics Inc.
10320748
In Commercial Distribution

  • 00630414112343 ()
  • 00630414009469 ()
476378

  • Laboratory pH electrode
The product is intended for the quantitative in vitro determination of Haemoglobin A1c concentration in whole blood.
RANDOX LABORATORIES LIMITED
HA8321
In Commercial Distribution

  • 05055273208856 ()
HA8321

  • Glycated haemoglobin (HbA1c) IVD, reagent
Enzymatic assay for the quantitative in vitro determination of glycated protein (fructosamine) in human serum or plasma.
RANDOX LABORATORIES LIMITED
FR3133
In Commercial Distribution

  • 05055273208726 ()
FR3133

  • Fructosamine IVD, reagent
The device is intended for the quantitative in vitro determination of Cystatin C in serum or plasma.
RANDOX LABORATORIES LIMITED
CYS4004
In Commercial Distribution

  • 05055273208665 ()
CYS4004

  • Cystatin C IVD, reagent
The is intended for the quantitative in vitro diagnostic determination of Creatinine in serum, plasma or urine
RANDOX LABORATORIES LIMITED
CR8316
In Commercial Distribution

  • 05055273208634 ()
CR8316

  • Creatinine IVD, reagent
The device is intended for the quantitative in vitro determination of carbon dioxide in serum or plasma.
RANDOX LABORATORIES LIMITED
CD4006
In Commercial Distribution

  • 05055273208375 ()
CD4006

  • Bicarbonate (HCO3-) IVD, reagent
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