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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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Trel-XPress 300, 10cc is made using demineralized human bone mixed with poloxamer resorbable reverse phase medium. Trel-Xpress 300 is formulated into a putty form and is provided in a sterile, single use package.
Integra Lifesciences Corporation
XPRES310
In Commercial Distribution

  • 10381780112549 ()
  • M386XPRES3101 ()

  • 10cc
XPRES310

  • Bone matrix implant, human-derived
The MediByte is a portable sleep data recorder used to record physiological signals during sleep while the patient is either at home or in a clinical environment. This is a warranty replacement unit.
Braebon Medical Corporation
MP8-W
In Commercial Distribution

  • B140MP8W0 ()
MP8-W

  • Polysomnograph
The Canady Hybrid Plasma GIT Side Fire probe is an electrosurgical plasma probe that is 2.3 mm in diameter and 2.3 m long. The electrosurgical plasma probe is used to coagulate biological tissue.
US MEDICAL INNOVATIONS, LLC
AW-422540
In Commercial Distribution

  • B413AW4225400 ()


  • Inert gas-enhanced endoscopic electrosurgical electrode, single-use
Accell TBM, 7 cm diameter - is made using demineralized human bone and is provided in the form of a freeze-dried matrix in a sheet or “wafer” format. Accell TBM is not an injectable putty.
ISOTIS ORTHOBIOLOGICS, INC.
02-4000-760
In Commercial Distribution

  • M3860240007601 ()
  • 10889981055660 ()

  • 7cm Round
02-4000-760

  • Bone matrix implant, human-derived
Velacur is a portable ultrasonic elastography machine used to assess and monitor chronic liver diseases. The device is comprised of a control unit, activation unit, and ultrasound probe. A carrying case is also provided.
Sonic Incytes Medical Corp.
LI-1005
In Commercial Distribution

  • B995LI10050 ()


  • Hepatic ultrasound elastography system
The MediByte is a portable sleep data recorder used to record physiological signals during sleep while the patient is either at home or in a clinical environment. This is a new warranty replacement unit.
Braebon Medical Corporation
MP8-WN
In Commercial Distribution

  • B140MP8WN0 ()
MP8-WN

  • Polysomnograph
The MediByte Jr. is a portable sleep data recorder used to record physiological signals during sleep while the patient is either at home or in a clinical environment. This is a warranty replacement unit.
Braebon Medical Corporation
MBJR-W
In Commercial Distribution

  • B140MBJRW0 ()
MBJR-W

  • Polysomnograph
BandLok is intended for use as a chemical cure band cement. This is the 6 gm syringe of Part A, natural shade.
RELIANCE ORTHODONTIC PRODUCTS INC
BLSA
In Commercial Distribution

  • D798BLSA0 ()
BLSA

  • Orthodontic bracket adhesive
Excel Fast is intended for use as a bracket adhesive. This is the Fast Set adhesive Part B in a 6gm syringe
RELIANCE ORTHODONTIC PRODUCTS INC
1EFSB
In Commercial Distribution

  • D7981EFSB0 ()
1EFSB

  • Orthodontic bracket adhesive
Stainless Steel Ortho FlexTech Lingual Retention System is intended for use as a Lingual Retainer Wire. This is the Stainless Steel version.
RELIANCE ORTHODONTIC PRODUCTS INC
SSOFT
In Commercial Distribution

  • D798SSOFTSAM0 ()
SSOFT

  • Orthodontic retainer
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