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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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Phase II is intended for use in direct and indirect bonding of orthodontic brackets and appliances. This is a chemical cure device. This kit contains: 18g Part A Adhesive, 18g Phase II Part B adhesive, 7g Maximum Cure Bonding Resin A with fluoride & 7 gm Maximum Cure Bonding Resin Part B, 9g Etchant, mixing pad, spatulas, disposable brushes This is a Fluoride Kit with Maximum Cure Sealants.
RELIANCE ORTHODONTIC PRODUCTS INC
PJMCF
Not in Commercial Distribution

  • D798PJMCF0 ()
PJMCF

  • Orthodontic bracket adhesive
The "Zeto All-in-One Medical Grade PC" is an accessory of the Zeto ONE, which is an EEG system intended for prescription use in healthcare facility, home, and specific transport environments to acquire, transmit, display and store EEG and auxiliary signals for adults and children, not including newborns. The product is intended to supplement the control of the Zeto ONE when attached to a medical cart.
ZETO INC
ZP-340-70001
In Commercial Distribution

  • B675MM0 ()


  • Electroencephalograph
The Bio SB Automated TintoStainer is an automated 36, 48, or 72 slide system for use in Immunohistochemistry (IHC) and Immunocytochemistry (ICC). The TintoStainer is perfect for laboratories that have a need increase work-flow efficiency through automation, yet want to maintain low operating costs. The TintoStainer is a rapid, flexible, open and affordable solution which allows for fast implementation of laboratory protocols while keeping a compact footprint.
BIO SB, INC.
TintoStainer 36 (110V)
Not in Commercial Distribution

  • B502BSB70290 ()
BSB 7029

  • Microscope slide stainer IVD
QuickProfile™ 2019-nCoV IgG/IgM Test Card is an immunochromatography based one step in vitro test. It is designed for the rapid qualitative determination of IgG and IgM antibodies to the 2019 novel coronavirus (2019-nCoV, SARS-CoV-2) in human serum, plasma, or whole blood. QuickProfile™ 2019-nCoV IgG/IgM Test Card is a supplemental rapid screening tool for symptomatic or asymptomatic carriers of the virus.
LUMIQUICK DIAGNOSTICS, INC.
71108B
In Commercial Distribution

  • M90171108B1 ()
  • M90171108B0 ()
  • M90171108B2 ()

  • Length: 80 Millimeter
71108B

  • SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical
The Integra® MemoFix® staple is a one piece single use nickel titanium alloy bone fixation device intended to be permanently implanted. The device is indicated for the fixation of osteotomies and joint arthrodesis of the hands and feet. The implant consists of two legs connected by a bridge and is offered in multiple combinations of bridge widths and leg lengths to accommodate various anatomies.
Ascension Orthopedics, Inc.
MS252222
In Commercial Distribution

  • M268MS2522221 ()
  • 10381780121510 ()

  • 25 mm W x 22 mm L x 22 mm L
MS252222

  • Orthopaedic bone staple, non-adjustable
The Integra® MemoFix® staple is a one piece single use nickel titanium alloy bone fixation device intended to be permanently implanted. The device is indicated for the fixation of osteotomies and joint arthrodesis of the hands and feet. The implant consists of two legs connected by a bridge and is offered in multiple combinations of bridge widths and leg lengths to accommodate various anatomies.
Ascension Orthopedics, Inc.
MS252020
In Commercial Distribution

  • M268MS2520201 ()
  • 10381780121503 ()

  • 25 mm W x 20 mm L x 20 mm L
MS252020

  • Orthopaedic bone staple, non-adjustable
The Integra® MemoFix® staple is a one piece single use nickel titanium alloy bone fixation device intended to be permanently implanted. The device is indicated for the fixation of osteotomies and joint arthrodesis of the hands and feet. The implant consists of two legs connected by a bridge and is offered in multiple combinations of bridge widths and leg lengths to accommodate various anatomies.
Ascension Orthopedics, Inc.
MS202020
In Commercial Distribution

  • M268MS2020201 ()
  • 10381780121497 ()

  • 20 mm W x 20 mm L x 20 mm L
MS202020

  • Orthopaedic bone staple, non-adjustable
The Integra® MemoFix® staple is a one piece single use nickel titanium alloy bone fixation device intended to be permanently implanted. The device is indicated for the fixation of osteotomies and joint arthrodesis of the hands and feet. The implant consists of two legs connected by a bridge and is offered in multiple combinations of bridge widths and leg lengths to accommodate various anatomies.
Ascension Orthopedics, Inc.
MS201515
In Commercial Distribution

  • M268MS2015151 ()
  • 10381780121480 ()

  • 20 mm W x 15 mm L x 15 mm L
MS201515

  • Orthopaedic bone staple, non-adjustable
The Integra® MemoFix® staple is a one piece single use nickel titanium alloy bone fixation device intended to be permanently implanted. The device is indicated for the fixation of osteotomies and joint arthrodesis of the hands and feet. The implant consists of two legs connected by a bridge and is offered in multiple combinations of bridge widths and leg lengths to accommodate various anatomies.
Ascension Orthopedics, Inc.
MS181917
In Commercial Distribution

  • M268MS1819171 ()
  • 10381780121473 ()

  • 18 mm W x 19 mm L x 17 mm L
MS181917

  • Orthopaedic bone staple, non-adjustable
The Integra® MemoFix® staple is a one piece single use nickel titanium alloy bone fixation device intended to be permanently implanted. The device is indicated for the fixation of osteotomies and joint arthrodesis of the hands and feet. The implant consists of two legs connected by a bridge and is offered in multiple combinations of bridge widths and leg lengths to accommodate various anatomies.
Ascension Orthopedics, Inc.
MS181715
In Commercial Distribution

  • M268MS1817151 ()
  • 10381780121466 ()

  • 18 mm W x 17 mm L x 15 mm L
MS181715

  • Orthopaedic bone staple, non-adjustable
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