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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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Visualize:Vascular is software that renders 3D images of vascular segments from ultrasound imaging.
SALIENT IMAGING
1.2
In Commercial Distribution

  • B725INITVV1 ()
  • B725INITVV12 ()
INITVV

  • Ultrasound imaging system application software
Narrow Introducer for Extended Heights H is greater than or equal to 10
Spineup, Inc.
RO0004NIEH
In Commercial Distribution

  • B806RO0004NIEH0 ()
RO0004NIEH

  • Orthopaedic inorganic implant inserter/extractor, reusable
The ResQPOD ITD 10 is indicated for the temporary increase in blood circulation.
ADVANCED CIRCULATORY SYSTEMS INC
12-0242-000
In Commercial Distribution

  • M5921202420000 ()
  • M5921202420001 ()
  • M5921202420002 ()


  • Cardiopulmonary resuscitation impedance valve, inspiratory
Retainium is intended for use as a lingual retention wire 0.016mm diameter wire
RELIANCE ORTHODONTIC PRODUCTS INC
XLRET
In Commercial Distribution

  • D798XLRET1 ()
  • D798RET0 ()
XLRET

  • Orthodontic retainer
Ultra Violet Mini Light is used to fluoresce materials that contain fluorescing agents
RELIANCE ORTHODONTIC PRODUCTS INC
UVML
In Commercial Distribution

  • D798UVML0 ()
UVML

  • Ultraviolet view box
Therma-Cure is intended for use as a heat curable adhesive for indirect bonding.
RELIANCE ORTHODONTIC PRODUCTS INC
TC
In Commercial Distribution

  • D798TC0 ()
TC

  • Denture base resin kit, heat-cured
Furcation Curette Set is composed of 2 Curettes buccal-lingual 2 Curettes mesial-distal and
A. Schweickhardt GmbH & Co. KG
3308-100
In Commercial Distribution

  • E89633081000 ()
3308-100

  • Periodontal curette
Insert W1 is used to perforate the bone, creating the initial pilot osteotomy.
MECTRON SPA
W1 -US-
In Commercial Distribution

  • E322045700011010 ()
04570001-101

  • Dental ultrasonic surgical system handpiece tip
eNcounterCloud is a secure cloud-based web application for medical image archiving and management.
Globalmed Holdings, LLC
2.3.x.x
In Commercial Distribution

  • B377GMD306100XXX0 ()


  • Multidisciplinary medical image management software
The Fin-Lock Instrument Tray Base is the botom portion wherein devices are placed.
Ascension Orthopedics, Inc.
CSA-0926-01
In Commercial Distribution

  • M269CSA0926011 ()
  • 10381780258155 ()

  • 21.20 in L x 9.80 in W x 3.79 in H


  • Instrument tray, reusable
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