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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G500, MINIRITE T 312 2.4G C092 AGXO
Oticon A/S
177230
In Commercial Distribution

  • 05711584071700 ()


  • Air-conduction hearing aid, receiver-in-the-ear
The P2131-2 Water Recovery System (WRS) is the water recycling and vacuum source component of the P2131 Automated Field Sterilizer system. The WRS reclaims hot condensate and exhaust steam for re-use by the sterilizer. The WRS also includes a water eductor, which provides the vacuum capability for the pre and post-vacuum phases of sterilization. The P2131 is an automated, pre- and post-vacuum steam sterilizer designed for sterilization of porous and non-porous, heat- and moisture-stable materials (e.g., surgical instruments and textiles) used in healthcare facilities. The P2131 sterilizer is a transportable device designed for field use in a variety of austere environments. The P2131 sterilizer consists of three components that work together as one integrated system. These components are the (1) Sterilizer Main Unit (SMU), (2) Water Recovery System (WRS), and (3) the Sterilizer Water Softener (SWS).
FORT DEFIANCE INDUSTRIES, LLC
P2131-2
In Commercial Distribution

  • 00862992000327 ()

  • Weight: 170 Pound
  • Height: 24.5 Inch
  • Width: 23.75 Inch
  • Length: 30 Inch


  • Steam sterilizer
G300, MINIRITE T 312 2.4G C063 HHM
Oticon A/S
177228
In Commercial Distribution

  • 05711584071687 ()


  • Air-conduction hearing aid, receiver-in-the-ear
The P2131 Automated Field Sterilizer (AFS) is an automated, pre- and post-vacuum steam sterilizer designed for sterilization of porous and non-porous, heat- and moisture-stable materials (e.g., surgical instruments and textiles) used in healthcare facilities. The P2131 sterilizer is a transportable device designed for field use in a variety of austere environments. The P2131 sterilizer consists of three components that work together as one integrated system. These components are the (1) Sterilizer Main Unit (SMU), (2) Water Recovery System (WRS), and (3) the Sterilizer Water Softener (SWS).
FORT DEFIANCE INDUSTRIES, LLC
P2131
In Commercial Distribution

  • 00862992000303 ()

  • Weight: 532 Pound
  • Height: 62 Inch
  • Width: 39.75 Inch
  • Length: 38 Inch


  • Steam sterilizer
UltraLinq is a web-based software application that provides image processing and viewing tools and access to studies and reports from a web-enabled computer, iPad or iPhone. UltraLinq is intended for use by a physician or other trained medical professionals to receive, process, review, display and archive medical images and data from imaging modalities. Diagnosis is not performed by the software but by qualified Physicians. UltraLinq is also intended for non-invasive processing of already acquired echocardiographic images in order to detect, measure, and calculate the left ventricular wall for left ventricular function evaluation. This measurement, available on workstations only, can be used to assist the clinician in a cardiac evaluation. UltraLinq conforms to the ACR/NEMA DICOM 3.0 standard for interoperability with other DICOM compliant systems.
ULTRALINQ HEALTHCARE SOLUTIONS, INC.
58.13
In Commercial Distribution

  • 00862894000302 ()


  • Multidisciplinary medical image management software
G300, MINIRITE T 312 2.4G C044 HHM
Oticon A/S
177216
In Commercial Distribution

  • 05711584071618 ()


  • Air-conduction hearing aid, receiver-in-the-ear
G300, MINIRITE T 312 2.4G C091 HHM
Oticon A/S
177214
In Commercial Distribution

  • 05711584071595 ()


  • Air-conduction hearing aid, receiver-in-the-ear
G400, MINIRITE T 312 2.4G C044 HHM
Oticon A/S
177210
In Commercial Distribution

  • 05711584071557 ()


  • Air-conduction hearing aid, receiver-in-the-ear
G400, MINIRITE T 312 2.4G C091 HHM
Oticon A/S
177208
In Commercial Distribution

  • 05711584071533 ()


  • Air-conduction hearing aid, receiver-in-the-ear
G500, MINIRITE T 312 2.4G C094 HHM
Oticon A/S
177205
In Commercial Distribution

  • 05711584071502 ()


  • Air-conduction hearing aid, receiver-in-the-ear
White plastic nose cone which slips over tip and provides means of tightening tip to insert. (For use with Sonus V device)
ENGLER ENGINEERING CORPORATION
806-1105
In Commercial Distribution

  • 00862872000348 ()
806-1105

  • Ultrasonic dental scaling/debridement system handpiece tip, periodontal
Bone Void Filler Kit, 3cc
AUSTIN MEDICAL VENTURES INC.
50-003
In Commercial Distribution

  • 00862835000477 ()

  • Weight: 25 Gram
50-003

  • Bone matrix implant, synthetic, non-antimicrobial
Bone Void Filler Kit, 20cc
AUSTIN MEDICAL VENTURES INC.
50-020
In Commercial Distribution

  • 00862835000453 ()

  • Weight: 25 Gram
50-020

  • Bone matrix implant, synthetic, non-antimicrobial
Bone Void Filler Kit, 5cc
AUSTIN MEDICAL VENTURES INC.
50-005
In Commercial Distribution

  • 00862835000446 ()

  • Weight: 25 Gram
50-005

  • Bone matrix implant, synthetic, non-antimicrobial
Bone Void Filler Kit, 10cc
AUSTIN MEDICAL VENTURES INC.
50-010
In Commercial Distribution

  • 00862835000439 ()

  • Weight: 25 Gram
50-010

  • Bone matrix implant, synthetic, non-antimicrobial
Calcium Sulfate Bone Void Filler, Large
AUSTIN MEDICAL VENTURES INC.
20-150
In Commercial Distribution

  • 00862835000422 ()

  • Weight: 50 Gram
20-150

  • Bone matrix implant, synthetic, non-antimicrobial
Calcium Sulfate Bone Void Filler, Medium
AUSTIN MEDICAL VENTURES INC.
20-125
In Commercial Distribution

  • 00862835000415 ()

  • Weight: 25 Gram
20-125

  • Bone matrix implant, synthetic, non-antimicrobial
Calcium Sulfate Bone Void Filler, Small
AUSTIN MEDICAL VENTURES INC.
20-112
In Commercial Distribution

  • 00862835000408 ()

  • Weight: 12 Gram
20-112

  • Bone matrix implant, synthetic, non-antimicrobial
ZR5 MNR, 2.4G NFM PB MAC/MSIL ZERENA 5
Bernafon AG
177138
In Commercial Distribution

  • 05711584070970 ()


  • Air-conduction hearing aid, receiver-in-the-ear
ZR5 MNR, 2.4G NFM PB MSIL ZERENA 5
Bernafon AG
177136
In Commercial Distribution

  • 05711584070956 ()


  • Air-conduction hearing aid, receiver-in-the-ear
ZR5 MNR, 2.4G NFM PB COBR ZERENA 5
Bernafon AG
177135
In Commercial Distribution

  • 05711584070949 ()


  • Air-conduction hearing aid, receiver-in-the-ear
ZR5 MNR, 2.4G NFM PB SABE/MSIL ZERENA 5
Bernafon AG
177134
In Commercial Distribution

  • 05711584070932 ()


  • Air-conduction hearing aid, receiver-in-the-ear
ZR5 MNR, 2.4G NFM PB MAC ZERENA 5
Bernafon AG
177133
In Commercial Distribution

  • 05711584070925 ()


  • Air-conduction hearing aid, receiver-in-the-ear
ZR5 MNR, 2.4G NFM PB ANBR ZERENA 5
Bernafon AG
177132
In Commercial Distribution

  • 05711584070918 ()


  • Air-conduction hearing aid, receiver-in-the-ear
ZR5 MNR, 2.4G NFM PB MSIL/MAC ZERENA 5
Bernafon AG
177131
In Commercial Distribution

  • 05711584070901 ()


  • Air-conduction hearing aid, receiver-in-the-ear
ZR5 MNR, 2.4G NFM PB SABE/MAC ZERENA 5
Bernafon AG
177130
In Commercial Distribution

  • 05711584070895 ()


  • Air-conduction hearing aid, receiver-in-the-ear
ZR7 MNR, 2.4G NFM PB MAC/MSIL ZERENA 7
Bernafon AG
177129
In Commercial Distribution

  • 05711584070888 ()


  • Air-conduction hearing aid, receiver-in-the-ear
ZR7 MNR, 2.4G NFM PB JEBL ZERENA 7
Bernafon AG
177128
In Commercial Distribution

  • 05711584070871 ()


  • Air-conduction hearing aid, receiver-in-the-ear
ZR7 MNR, 2.4G NFM PB COBR ZERENA 7
Bernafon AG
177126
In Commercial Distribution

  • 05711584070864 ()


  • Air-conduction hearing aid, receiver-in-the-ear
ZR7 MNR, 2.4G NFM PB MAC ZERENA 7
Bernafon AG
177124
In Commercial Distribution

  • 05711584070857 ()


  • Air-conduction hearing aid, receiver-in-the-ear
ZR7 MNR, 2.4G NFM PB ANBR ZERENA 7
Bernafon AG
177123
In Commercial Distribution

  • 05711584070840 ()


  • Air-conduction hearing aid, receiver-in-the-ear
ZR7 MNR, 2.4G NFM PB MSIL/MAC ZERENA 7
Bernafon AG
177122
In Commercial Distribution

  • 05711584070833 ()


  • Air-conduction hearing aid, receiver-in-the-ear
ZR7 MNR, 2.4G NFM PB SABE/MAC ZERENA 7
Bernafon AG
177121
In Commercial Distribution

  • 05711584070826 ()


  • Air-conduction hearing aid, receiver-in-the-ear
ZR7 MNR, 2.4G NFM PB MSIL ZERENA 7
Bernafon AG
177127
In Commercial Distribution

  • 05711584070789 ()


  • Air-conduction hearing aid, receiver-in-the-ear
ZR7 MNR, 2.4G NFM PB SABE/MSIL ZERENA 7
Bernafon AG
177125
In Commercial Distribution

  • 05711584070772 ()


  • Air-conduction hearing aid, receiver-in-the-ear
ZR9 B 105, 2.4G NFM DPB SABE/MAC DEMO ZERENA 9
Bernafon AG
177045
In Commercial Distribution

  • 05711584070475 ()


  • Air-conduction hearing aid, behind-the-ear
ZR5 B 105, 2.4G NFM DPB MAC/MSIL ZERENA 5
Bernafon AG
176806
In Commercial Distribution

  • 05711584070468 ()


  • Air-conduction hearing aid, behind-the-ear
ZR5 B 105, 2.4G NFM DPB JEBL ZERENA 5
Bernafon AG
176805
In Commercial Distribution

  • 05711584070451 ()


  • Air-conduction hearing aid, behind-the-ear
ZR5 B 105, 2.4G NFM DPB COBR ZERENA 5
Bernafon AG
176804
In Commercial Distribution

  • 05711584070444 ()


  • Air-conduction hearing aid, behind-the-ear
ZR5 B 105, 2.4G NFM DPB MSIL ZERENA 5
Bernafon AG
176803
In Commercial Distribution

  • 05711584070437 ()


  • Air-conduction hearing aid, behind-the-ear
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