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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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Calcium compound bone void filler with DBM (5cc), Previously sold under Trabexus® EB brand name.
Vivorte, Inc
5 cc
In Commercial Distribution

  • W4146EB0005T0475 ()
130703-05

  • Cadaveric-donor/synthetic mineral bone graft
Self-contained biological indicator for use in steam sterilization processes. Log 5 population. 25 count box.
MESA LABORATORIES, INC.
Log 5
In Commercial Distribution

  • M985SEZS5251 ()
  • M985SEZS5250 ()
SEZS/525

  • Biological sterilization indicator
Self-contained biological indicator for use in steam sterilization. Log 5. 50 count package.
MESA LABORATORIES, INC.
Log 5
Not in Commercial Distribution

  • M985PS235501 ()
  • M985PS235500 ()
PS2-3-5-50

  • Biological sterilization indicator
Biological Indicator intended for steam sterilization (121C). Contains spores of Geobacillus stearothermophilus. 50 units / box
MESA LABORATORIES, INC.
Log 5
Not in Commercial Distribution

  • M985PS2351 ()
  • M985PS23550 ()
PS2-3-5-50

  • Biological sterilization indicator
Instant Cold Pack
Jeg & Sons Inc.
5 Pack
In Commercial Distribution

  • 00810084938355 ()
  • 00810084936887 ()
FMN100525

  • Hot/cold therapy pack, single-use
Plug T1 5 cm is a macroporous round preshaped flat plug, indicated for the treatment of inguinal hernia defect with open technique.
HERNIAMESH SRL
PT1/5
In Commercial Distribution

  • 18032919891041 ()
  • 58032919891049 ()


  • Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable
Anti-scatter X-ray Grid used as part of Digital X-ray Imaging System that is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
Samsung Electronics Co., Ltd.
Grid 5
In Commercial Distribution

  • 08806088508931 ()


  • Stationary x-ray grid
TI ECCENTER-STERILE
SYNTHES (U.S.A.) LP
5413-20/5
Not in Commercial Distribution

  • H67954132050 ()
  • 10886982241313 ()
5413205

  • Shoulder humeral body prosthesis
No Description
Merete GmbH
right 5
In Commercial Distribution

  • 04048266135896 ()

  • Wedge 5 mm
FH13005

  • Orthopaedic fixation plate, non-bioabsorbable
No Description
Merete GmbH
left 5
In Commercial Distribution

  • 04048266135865 ()

  • Wedge 5 mm
FH12005

  • Orthopaedic fixation plate, non-bioabsorbable
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