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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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LIFECODES QuikScreen assay is a qualitative solid phase enzyme linked immunosorbent assay (ELISA) designed to detect IgG antibodies to HLA class I antigens.
IMMUCOR GTI DIAGNOSTICS, INC.
QS12G
Not in Commercial Distribution

  • 10888234500094 ()
QS12G

  • HLA class I antibody screening IVD, kit, enzyme immunoassay (EIA)
ARK™ Methotrexate II Dilution Buffer is intended for dilution of specimens containing high concentrations of methotrexate for the ARK Methotrexate II Assay.
ARK DIAGNOSTICS INC
5071-0004-00
In Commercial Distribution

  • 00812101031223 ()
5071-0004-00

  • Methotrexate therapeutic drug monitoring IVD, calibrator
Haemostatic Gauze: Non-woven Gauze coated with Celox haemostatic granules. Device is indicated to control moderate to severe bleeding. For temporary external use only.
MEDTRADE PRODUCTS LIMITED
FG08838011
In Commercial Distribution

  • 75060206630030 ()
  • 15060206630038 ()

  • Length: 10 Feet
  • Width: 3 Inch
  • Gauze 3in x 10ft
FG08838011

  • Chitosan haemostatic agent, professional, non-bioabsorbable
The NEATCAP® DREAMIES® device is a single use medical device designed to provide hearing protection for infants in a neonatal or pediatric intensive care unit. The Size XL device is designed for use on infants with a head circumference measuring 41-48cm. NEATCAP® DREAMIES® devices are packaged non-sterile.
NEATCAP MEDICAL LLC
Size XL
In Commercial Distribution

  • 00860008980793 ()
NEAT004-05

  • Infant acoustic earmuffs
The NEATCAP® DREAMIES® device is a single use medical device designed to provide hearing protection for infants in a neonatal or pediatric intensive care unit. The Size LG device is designed for use on infants with a head circumference measuring 35-41cm. NEATCAP® DREAMIES® devices are packaged non-sterile.
NEATCAP MEDICAL LLC
Size LG
In Commercial Distribution

  • 00860008980786 ()
NEAT004-04

  • Infant acoustic earmuffs
The NEATCAP® DREAMIES® device is a single use medical device designed to provide hearing protection for infants in a neonatal or pediatric intensive care unit. The Size M device is designed for use on infants with a head circumference measuring 31-35cm. NEATCAP® DREAMIES® devices are packaged non-sterile.
NEATCAP MEDICAL LLC
Size M
In Commercial Distribution

  • 00860008980779 ()
NEAT004-03

  • Infant acoustic earmuffs
The NEATCAP® DREAMIES® device is a single use medical device designed to provide hearing protection for infants in a neonatal or pediatric intensive care unit. The Size S device is designed for use on infants with a head circumference measuring 27-31cm. NEATCAP® DREAMIES® devices are packaged non-sterile.
NEATCAP MEDICAL LLC
Size S
In Commercial Distribution

  • 00860008980762 ()
NEAT004-02

  • Infant acoustic earmuffs
The NEATCAP® DREAMIES® device is a single use medical device designed to provide hearing protection for infants in a neonatal or pediatric intensive care unit. The Size XS device is designed for use on infants with a head circumference measuring 23-27cm. NEATCAP® DREAMIES® devices are packaged non-sterile.
NEATCAP MEDICAL LLC
Size XS
In Commercial Distribution

  • 00860008980755 ()
NEAT004-01

  • Infant acoustic earmuffs
The FFX implant is a sterile, single patient use, long-term implantable devices consisting of a D-shaped cage made of titanium with an oval shape that is designed to be filled with bone graft. The top and bottom surfaces of the cage have sawtooth-shaped surface to improve fixation to the bone.
SC MEDICA
57.000.60S
In Commercial Distribution

  • 03770019503058 ()


  • Spinal bone screw, non-bioabsorbable
The FFX implant is a sterile, single patient use, long-term implantable devices consisting of a D-shaped cage made of titanium with an oval shape that is designed to be filled with bone graft. The top and bottom surfaces of the cage have sawtooth-shaped surface to improve fixation to the bone.
SC MEDICA
57.000.50S
In Commercial Distribution

  • 03770019503041 ()


  • Spinal bone screw, non-bioabsorbable
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