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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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Accell Connexus, 5cc - demineralized human bone mixed with poloxamer reverse phase medium. Accell Connexus is formulated into a putty form and is provided in a sterile, single use package
ISOTIS ORTHOBIOLOGICS, INC.
02-3000-050
In Commercial Distribution

  • M3860230000501 ()
  • 10889981055486 ()

  • 5cc
02-3000-050

  • Bone matrix implant, human-derived
Accell Connexus, 2.5cc - demineralized human bone mixed with poloxamer reverse phase medium. Accell Connexus is formulated into a putty form and is provided in a sterile, single use package
ISOTIS ORTHOBIOLOGICS, INC.
02-3000-025
In Commercial Distribution

  • M3860230000251 ()
  • 10889981055479 ()

  • 2.5cc
02-3000-025

  • Bone matrix implant, human-derived
Accell Connexus, 1cc - demineralized human bone mixed with poloxamer reverse phase medium. Accell Connexus is formulated into a putty form and is provided in a sterile, single use package
ISOTIS ORTHOBIOLOGICS, INC.
02-3000-010
In Commercial Distribution

  • M3860230000101 ()
  • 10889981055462 ()

  • 1cc
02-3000-010

  • Bone matrix implant, human-derived
Accell Connexus, 0.5cc - demineralized human bone mixed with poloxamer reverse phase medium. Accell Connexus is formulated into a putty form and is provided in a sterile, single use package
ISOTIS ORTHOBIOLOGICS, INC.
02-3000-005
In Commercial Distribution

  • M3860230000051 ()
  • 10889981055455 ()

  • 0.5cc
02-3000-005

  • Bone matrix implant, human-derived
QuantX is a software program that analyzes patient breast images, and is designed to aid radiologists in the characterization of lesions as part of high-risk screening or diagnostic work-up.
QLARITY IMAGING, LLC
Breast MRI
In Commercial Distribution

  • B80711 ()
1

  • Radiological PACS software
Core Cognitive Evaluation is a non-invasive test that assess possible cognitive impairment. It is intended to be used by medical professionals qualified to interpret results of a cognitive assessment.
Linus Health, Inc.
20001
Not in Commercial Distribution

  • B626200010 ()
20001

  • Cognitive assessment software
Maximum CureĀ® Sealants are intended for use in direct and indirect bonding of brackets and appliances. This is the 7g bottle Part B. This is the Filled version.
RELIANCE ORTHODONTIC PRODUCTS INC
MCFSB
In Commercial Distribution

  • D798MCFSB0 ()
MCFSB

  • Dental composite resin
Phase II is intended for use in direct and indirect bonding of orthodontic brackets and appliances. This is the Phase II Part A Non-Fluoride in 6 gm screw syringe.
RELIANCE ORTHODONTIC PRODUCTS INC
1PSA
In Commercial Distribution

  • D7981PSA0 ()
1PSA

  • Orthodontic bracket adhesive
The Etchmaster system is intended for use as a microetcher of a surface prior to bonding with an orthodontic adhesive. This is the Handpiece for connection to an airline.
RELIANCE ORTHODONTIC PRODUCTS INC
EMHAR
In Commercial Distribution

  • D798EMHAR0 ()
EMHAR

  • Dental abrasive air jet system
The VIDEOSTAR is a digital videoscopy system. It is designed to allow qualified personnel to visualize eye reaction of the patient and record digital video. Freefield videonystagmoscope digital USB2
Instrumentation Difra SA
VIDEOSTAR II
In Commercial Distribution

  • B51622092 ()
22092

  • Posturography system platform
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