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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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S&N 400 INSUFFLATOR KIT US
Smith & Nephew, Inc.
7209933
In Commercial Distribution

  • 00885554012286 ()
7209933

  • Insufflation gas conditioning system control unit
S&N 400 INSUFFLATOR KIT SPANISH
Smith & Nephew, Inc.
7209939
In Commercial Distribution

  • 00885554011203 ()
7209939

  • Insufflation gas conditioning system control unit
DYONICS POWER ENGLISH KT 120V
Smith & Nephew, Inc.
7205886
In Commercial Distribution

  • 00885554010381 ()
7205886

  • Insufflation gas conditioning system control unit
MTO DYONICS POWER SPANISH KIT
Smith & Nephew, Inc.
7205893
Not in Commercial Distribution

  • 00885554009163 ()
7205893

  • Insufflation gas conditioning system control unit
DYONICS POWER U.K. KIT
Smith & Nephew, Inc.
7205887
In Commercial Distribution

  • 00885554008777 ()
7205887

  • Insufflation gas conditioning system control unit
RFB INSUFFLATORDYONICS(R)
Smith & Nephew, Inc.
7205832F
Not in Commercial Distribution

  • 00885556568125 ()
7205832F

  • Insufflation gas conditioning system control unit
DYONICS POWER II SHAVER SYSTEM CONTROL UNIT. ALL UNITS 100-240 VAC, 50/60 HZ SERVICE REPLACEMENT
Smith & Nephew, Inc.
72200873SR
In Commercial Distribution

  • 00885556624197 ()
72200873SR

  • Insufflation gas conditioning system control unit
Irrigation Solution Warmer, 9.4 Liter
Microtek Medical LLC
Fluid Warming - Warmer Equipment
In Commercial Distribution

  • 00748426140756 ()
ORS-2094R

  • Multi-purpose warming cabinet, mobile
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
RFB IN-LINE GAS WARMER
Smith & Nephew, Inc.
7205868F
In Commercial Distribution

  • 00885556608340 ()
7205868F

  • Insufflation gas conditioning system control unit
Green S-Type Extended Head Mask AccuPerf™ 2.4mm
Klarity Medical Products, LLC
RG460-5SHT
In Commercial Distribution

  • 00817355020139 ()


  • Patient positioning thermoplastic mould material
Green S-Type Head Mask 36% perforation 2.4mm
Klarity Medical Products, LLC
RG460SHT
In Commercial Distribution

  • 00817355020115 ()


  • Patient positioning thermoplastic mould material
Green S-Type Head & Shoulder Mask AccuPerf™ 2.4mm
Klarity Medical Products, LLC
RG460-4ST
In Commercial Distribution

  • 00817355020092 ()


  • Patient positioning thermoplastic mould material
Green S-Type Head & Shoulder Pediatric Mask 36% perforation 2.4mm
Klarity Medical Products, LLC
RG460SC
In Commercial Distribution

  • 00817355020078 ()


  • Patient positioning thermoplastic mould material
Klarity Green Proton Therapy Head and Shoulder Mask, 3.2mm W/PINS
Klarity Medical Products, LLC
RG461C
In Commercial Distribution

  • 00817355020054 ()
RG461C

  • Patient positioning thermoplastic mould material
Green S-Type Extended Head Mask AccuPerf™ 3.2mm
Klarity Medical Products, LLC
RG461-5SHT
In Commercial Distribution

  • 00817355020023 ()


  • Patient positioning thermoplastic mould material
Green S-Type Head Mask AccuPerf™ 3.2mm
Klarity Medical Products, LLC
RG461-4SHT
In Commercial Distribution

  • 00817355020016 ()


  • Patient positioning thermoplastic mould material
Klarity White Thermoplastic Sheet 11% perforation, 1.6mm, 610x460mm
Klarity Medical Products, LLC
P-1611A
In Commercial Distribution

  • 00817355020009 ()


  • Patient positioning thermoplastic mould material
Klarity R White ThermoSheet™ 36% perforation, 2.4mm, 610x460mm
Klarity Medical Products, LLC
R-2436A
In Commercial Distribution

  • 00817355027954 ()


  • Patient positioning thermoplastic mould material
Klarity LiteGreen™ Pelvic Mask for the UNO and S-type All in One System, 36% perforation, 2.4mm
Klarity Medical Products, LLC
RLG902-2436BA
In Commercial Distribution

  • 00817355027596 ()


  • Patient positioning thermoplastic mould material
Klarity Lite Green E-type Fraxion™ Open Face Head Mask with Extended Neckline 12% perforation, 2.4mm
Klarity Medical Products, LLC
RLG-ESH2-2412CF
In Commercial Distribution

  • 00817355027008 ()


  • Patient positioning thermoplastic mould material
Klarity Easy Fit Thermoplastic Sheet, 1% perforation, 3.2mm 920x610mm
Klarity Medical Products, LLC
EZ-3201
In Commercial Distribution

  • 00817355026674 ()


  • Patient positioning thermoplastic mould material
Klarity Pro Beige Thermoplastic Sheet no perforation, 3.2mm, 920x610mm
Klarity Medical Products, LLC
PS-3200
In Commercial Distribution

  • 00817355026186 ()


  • Patient positioning thermoplastic mould material
Klarity Contour Blend Thermoplastic Sheet no perforation, 2.4mm, 610x460mm
Klarity Medical Products, LLC
CB-2400A
In Commercial Distribution

  • 00817355025783 ()


  • Patient positioning thermoplastic mould material
Klarity Green Head and Shoulder Proton Mask 12% perforation 2.4mm with film
Klarity Medical Products, LLC
RG460C3
In Commercial Distribution

  • 00817355025769 ()


  • Patient positioning thermoplastic mould material
Klarity LiteGreen O-type 5-Point Head & Shoulder Mask 3.2mm
Klarity Medical Products, LLC
RDLG207-8A
In Commercial Distribution

  • 00817355025745 ()


  • Patient positioning thermoplastic mould material
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