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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Irrigation Solution Warmer, 7.5 Liter
Microtek Medical LLC
Fluid Warming - Warmer Equipment
In Commercial Distribution

  • 00748426140749 ()
ORS-2075R

  • Multi-purpose warming cabinet, mobile
Irrigation Solution Warmer, 6.6 Liter
Microtek Medical LLC
Fluid Warming - Warmer Equipment
In Commercial Distribution

  • 00748426140732 ()
ORS-2066R

  • Multi-purpose warming cabinet, mobile
Irrigation Solution Warmer, 5.7 Liter
Microtek Medical LLC
Fluid Warming - Warmer Equipment
In Commercial Distribution

  • 00748426140725 ()
ORS-2057D

  • Multi-purpose warming cabinet, mobile
Irrigation Solution Warmer, 3.8 Liter
Microtek Medical LLC
Fluid Warming - Warmer Equipment
In Commercial Distribution

  • 00748426140718 ()
ORS-2038D

  • Multi-purpose warming cabinet, mobile
Scope Cradle™, For Use with O.R. Solutions Warming Systems
Microtek Medical LLC
Fluid Warming - Warmer Equipment
In Commercial Distribution

  • 10748426140494 ()
  • 00748426140497 ()
ORS-6000

  • Multi-purpose warming cabinet, mobile
Quick Connect Adaptor
DEROYAL INDUSTRIES, INC.
28-0202
In Commercial Distribution

  • 00749756027946 ()
28-0202

  • Insufflation gas conditioning tubing set
Insufflation Filter
DEROYAL INDUSTRIES, INC.
28-0205NS
In Commercial Distribution

  • 50749756025398 ()
  • 00749756025393 ()
28-0205NS

  • Insufflation gas conditioning tubing set
Insufflation Tubing,Laparoscopic
DEROYAL INDUSTRIES, INC.
28-0201NS
In Commercial Distribution

  • 50749756024872 ()
  • 00749756024877 ()
28-0201NS

  • Insufflation gas conditioning tubing set
Insufflation Filter
DEROYAL INDUSTRIES, INC.
28-0203
In Commercial Distribution

  • 30749756024847 ()
  • 00749756024846 ()
  • 50749756024841 ()
28-0203

  • Insufflation gas conditioning tubing set
Insufflation Tubing,Laparoscopic
DEROYAL INDUSTRIES, INC.
28-0207
In Commercial Distribution

  • 50749756024582 ()
  • 00749756024587 ()
28-0207

  • Insufflation gas conditioning tubing set
Tubing,Insuf w/.1 Micr Filter Colored Tube
DEROYAL INDUSTRIES, INC.
V28-0201
In Commercial Distribution

  • 30749756024410 ()
  • 00749756024419 ()
  • 50749756024414 ()
V28-0201

  • Insufflation gas conditioning tubing set
Insufflation Tubing,Laparoscopic
DEROYAL INDUSTRIES, INC.
28-0201
In Commercial Distribution

  • 30749756024335 ()
  • 00749756024334 ()
  • 50749756024339 ()
28-0201

  • Insufflation gas conditioning tubing set
Klarity LiteGreen™ P-type 5-point Modified Open Face Head Mask, AccuPerf™, 2.4mm
Klarity Medical Products, LLC
RLG-PRT5-24AF1
In Commercial Distribution

  • 00817355029620 ()


  • Patient positioning thermoplastic mould material
Blue SRS Open Face Mask Set with 10% perforation, 3.2mm. Includes Bottom Mask, Open Face Top Mask, and Simple Shim System™
Klarity Medical Products, LLC
S-2000
Not in Commercial Distribution

  • 00817355024779 ()


  • Patient positioning thermoplastic mould material
Klarity Breakaway Shim for SRS mask
Klarity Medical Products, LLC
R-QST-6
In Commercial Distribution

  • 00817355029644 ()


  • Patient positioning thermoplastic mould material
Klarity LiteGreen™ Uno™ Long Torso Mask, 36% perforation, 2.4mm, 59cm x 46cm
Klarity Medical Products, LLC
RLG902-2436LA
In Commercial Distribution

  • 00817355028326 ()


  • Patient positioning thermoplastic mould material
Klarity LiteGreen™ Uno™ Head and Thorax Mask, 36% perforation, 2.4mm, 59cm x 46cm
Klarity Medical Products, LLC
RLG322-S42436
In Commercial Distribution

  • 00817355028296 ()


  • Patient positioning thermoplastic mould material
Klarity Blue™ SRS Mask Set, 10% perforation, 3.2mm. Includes: Anterior Mask and customizable Breakaway™ Shims
Klarity Medical Products, LLC
S-2007
In Commercial Distribution

  • 00817355029699 ()


  • Patient positioning thermoplastic mould material
Klarity Blue™ SRS Mask Set, 10% perforation, 3.2mm. Includes: Open Face Anterior Mask and customizable Breakaway™ Shims
Klarity Medical Products, LLC
S-2006
In Commercial Distribution

  • 00817355029552 ()


  • Patient positioning thermoplastic mould material
Klarity Blue™ SRS Mask Set, 10% perforation, 3.2mm. Includes: Posterior Mask, Anterior Mask, and customizable Breakaway™ Shims
Klarity Medical Products, LLC
S-2005
In Commercial Distribution

  • 00817355029545 ()


  • Patient positioning thermoplastic mould material
Klarity Blue™ SRS Mask Set, 10% perforation, 3.2mm. Includes: Posterior Mask, Open Face Anterior Mask, and customizable Breakaway™ Shims
Klarity Medical Products, LLC
S-2004
In Commercial Distribution

  • 00817355029538 ()


  • Patient positioning thermoplastic mould material
Protocol Administration Set With Flexi-Cuff Retention Tip CO2 Delivery System for Colon Insufflation
Bracco Diagnostics Inc.
390401
In Commercial Distribution

  • 30815112021574 ()
  • 10815112021570 ()

  • Catheter Gauge: 48 French
390401

  • Insufflation gas conditioning tubing set
Protocol Administration Set With Flexi-Cuff Retention Tip CO2 Delivery System for Colon Insufflation
Bracco Diagnostics Inc.
390401
In Commercial Distribution

  • 10815112020160 ()
  • 30815112020164 ()

  • Catheter Gauge: 48 French
390401

  • Insufflation gas conditioning tubing set
Disposable non-sterile (61 x 91.4cm) standard perforated thermoplastic (2.4mm)
MEDTEC, INC.
MTAPSX24362.4
Not in Commercial Distribution

  • 00841439103371 ()
  • 10841439103378 ()

  • Length: 36 Inch
MTAPSX24362.4

  • Patient positioning thermoplastic mould material
Circuit /LP Gen/No Prongs/ F&P 730 & 850 (Box/20)
Carefusion Corporation
26405-001
Not in Commercial Distribution

  • 70846446005907 ()
26405-001

  • Inspiratory/expiratory limb respiratory tubing, reusable
  • Ventilator breathing circuit, single-use
  • Respiratory gas heating wire, adult
Circuit /LP Gen/No Prongs/ F&P 730 & 850 (Box/10)
Carefusion Corporation
26404-001
Not in Commercial Distribution

  • 70846446005891 ()
26404-001

  • Respiratory gas heating wire, adult
  • Ventilator breathing circuit, single-use
  • Inspiratory/expiratory limb respiratory tubing, reusable
Duo-Pen is an endodontic device that uses heat to cut, soften, down-pack and compact the root canal filling material(Gutta Percha Obturators or Gutta Percha Points.)
DiaDent Group International
DUO-PEN HEATING CONDENSOR(04-50/06-50)
In Commercial Distribution

  • 08806383557351 ()
4007-2075

  • Endodontic obturation system
AQUA CLEANSE COLON IRRIGATION DEVICE
QUALITY MEDICAL SUPPLY, INC.
01
In Commercial Distribution

  • 00850014947163 ()


  • Colonic lavage unit
No Description
Ulthera, Inc.
UH-2 DS 2.0 Rev A
In Commercial Distribution

  • 00840763101152 ()


  • Ultrasound hyperthermia system transducer, extracorporeal
No Description
Ulthera, Inc.
UC-1 Control Unit (PRIME) Rev. A
In Commercial Distribution

  • 00840763101145 ()


  • Ultrasound hyperthermia system transducer, extracorporeal
No Description
Ulthera, Inc.
UT-4N Rev L
In Commercial Distribution

  • 00840763100896 ()


  • Ultrasound hyperthermia system transducer, extracorporeal
No Description
Ulthera, Inc.
UT-4 Rev L
In Commercial Distribution

  • 00840763100889 ()


  • Ultrasound hyperthermia system transducer, extracorporeal
No Description
Ulthera, Inc.
UT-1 Rev N
In Commercial Distribution

  • 00840763100865 ()


  • Ultrasound hyperthermia system transducer, extracorporeal
No Description
Ulthera, Inc.
UT-3 Rev N
In Commercial Distribution

  • 00840763100858 ()


  • Ultrasound hyperthermia system transducer, extracorporeal
No Description
Ulthera, Inc.
UT-2 Rev O
In Commercial Distribution

  • 00840763100841 ()


  • Ultrasound hyperthermia system transducer, extracorporeal
No Description
Ulthera, Inc.
UT-1N Rev N
In Commercial Distribution

  • 00840763100834 ()


  • Ultrasound hyperthermia system transducer, extracorporeal
No Description
Ulthera, Inc.
UT-1N Rev. H
In Commercial Distribution

  • 00840763100360 ()


  • Ultrasound hyperthermia system transducer, extracorporeal
No Description
Ulthera, Inc.
UT-3 Rev. H
In Commercial Distribution

  • 00840763100353 ()


  • Ultrasound hyperthermia system transducer, extracorporeal
No Description
Ulthera, Inc.
UT-4 Rev. G
In Commercial Distribution

  • 00840763100346 ()


  • Ultrasound hyperthermia system transducer, extracorporeal
No Description
Ulthera, Inc.
UT-2 Rev. J
In Commercial Distribution

  • 00840763100339 ()


  • Ultrasound hyperthermia system transducer, extracorporeal
No Description
Ulthera, Inc.
UT-4N Rev. G
In Commercial Distribution

  • 00840763100322 ()


  • Ultrasound hyperthermia system transducer, extracorporeal
No Description
Ulthera, Inc.
UT-1 Rev H
In Commercial Distribution

  • 00840763100315 ()


  • Ultrasound hyperthermia system transducer, extracorporeal
No Description
Ulthera, Inc.
UT-4N Rev. F
In Commercial Distribution

  • 00840763100070 ()


  • Ultrasound hyperthermia system transducer, extracorporeal
No Description
Ulthera, Inc.
UT-4 Rev. F
In Commercial Distribution

  • 00840763100063 ()


  • Ultrasound hyperthermia system transducer, extracorporeal
No Description
Ulthera, Inc.
UT-3 Rev. G
In Commercial Distribution

  • 00840763100056 ()


  • Ultrasound hyperthermia system transducer, extracorporeal
No Description
Ulthera, Inc.
UT-2 Rev. I
In Commercial Distribution

  • 00840763100049 ()


  • Ultrasound hyperthermia system transducer, extracorporeal
No Description
Ulthera, Inc.
UT-1N Rev. G
In Commercial Distribution

  • 00840763100032 ()


  • Ultrasound hyperthermia system transducer, extracorporeal
No Description
Ulthera, Inc.
UT-1 Rev G
Not in Commercial Distribution

  • 00840763100025 ()


  • Ultrasound hyperthermia system transducer, extracorporeal
GAS WARMER
Conmed Corporation
GS1012
Not in Commercial Distribution

  • 30845854045224 ()
  • 10845854045220 ()
GS1012

  • Insufflation gas conditioning system
Focused Ultrasound for tissue heat or mechanical cellular disruption
Jeisys Medical Inc.
LIPOcel
In Commercial Distribution

  • 08800020100009 ()


  • Ultrasound hyperthermia system transducer, extracorporeal
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