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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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Klarity Medical - 00817355022454

Light Green O-type 3-Point Head Mask (with nosehole) with 12% perforation, 2.4mm
Klarity Medical Products, LLC
RDLG105-2412C
In Commercial Distribution

  • 00817355022454 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355022447

Green E-type Fraxion™ Rounded Head Mask with 12% perforation, 2.4mm
Klarity Medical Products, LLC
RLG-ESH2-2412C
In Commercial Distribution

  • 00817355022447 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355022430

Klarity Cushion Custom 25x35cm
Klarity Medical Products, LLC
R550-CB
In Commercial Distribution

  • 00817355022430 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355022423

Klarity Cushion Medium 25x35cm
Klarity Medical Products, LLC
R550-M3
In Commercial Distribution

  • 00817355022423 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355022409

Light Green Head&Shoulder Mask 2.4mm, Perf 12% for Elekta HeadSTEP™ System
Klarity Medical Products, LLC
RLG-ELS-2412CN
In Commercial Distribution

  • 00817355022409 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355022393

Light Green Head Mask 2.4mm, Perf 12% for Elekta HeadSTEP™ System, With Nose Hole
Klarity Medical Products, LLC
RLG-ELH-2412CN
In Commercial Distribution

  • 00817355022393 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355022225

Klarity Custom Klarity Cushion™, 20x25cm 2 Liter Fill
Klarity Medical Products, LLC
R550-M2
In Commercial Distribution

  • 00817355022225 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355022218

Custom AccuCushion for Stanford University
Klarity Medical Products, LLC
1
In Commercial Distribution

  • 00817355022218 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355022201

Klarity Light Green Head Mask w/ Neckline For Elekta Icon 2.4mm 12% Perf
Klarity Medical Products, LLC
RLG-ESH3-2412CN
In Commercial Distribution

  • 00817355022201 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355022195

2.4mm Green AccuPerf O-type Open Face Head Mask
Klarity Medical Products, LLC
RDLG105-24AF
In Commercial Distribution

  • 00817355022195 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355022188

Klarity Green Proton Therapy Head Mask, 3.2mm NO PINS
Klarity Medical Products, LLC
RG461CH
In Commercial Distribution

  • 00817355022188 ()
RG461CH1

  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355022171

Klarity Green Proton Therapy Head and Shoulder Mask, 3.2mm NO PINS
Klarity Medical Products, LLC
RG461C
In Commercial Distribution

  • 00817355022171 ()
RG461C1

  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355022164

Klarity Green Head Mask Set for BrainLab Type-A System
Klarity Medical Products, LLC
RG406-4
In Commercial Distribution

  • 00817355022164 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355022157

3.2mm 42% Perf Green Versa Pediatric Head/Shoulder Mask
Klarity Medical Products, LLC
RG461VC
In Commercial Distribution

  • 00817355022157 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355022140

2.4mm 42% Perf Green Versa Pediatric Head/Shoulder Mask
Klarity Medical Products, LLC
RG460VC
In Commercial Distribution

  • 00817355022140 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355022133

3.2mm AccuPerf Green Versa Head/Shoulder Mask
Klarity Medical Products, LLC
RG461-4VT
In Commercial Distribution

  • 00817355022133 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355022126

2.4mm AccuPerf Green Versa Head/Shoulder Mask
Klarity Medical Products, LLC
RG460-4VT
In Commercial Distribution

  • 00817355022126 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355022119

2.4mm 36% Perf Green Versa Head/Shoulder Mask
Klarity Medical Products, LLC
RG460VT
In Commercial Distribution

  • 00817355022119 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355022102

3.2mm AccuPerf Green Versa Extended Head Mask
Klarity Medical Products, LLC
RG461-5VHT
In Commercial Distribution

  • 00817355022102 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355022096

2.4mm AccuPerf Green Versa Extended Head Mask
Klarity Medical Products, LLC
RG460-5VHT
In Commercial Distribution

  • 00817355022096 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355022089

3.2mm AccuPerf Green Versa Head Mask
Klarity Medical Products, LLC
RG461-4VHT
In Commercial Distribution

  • 00817355022089 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355022072

2.4mm AccuPerf Green Head Versa Mask
Klarity Medical Products, LLC
RG460-4VHT
In Commercial Distribution

  • 00817355022072 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355022065

2.4mm 36% Perf Green Versa Head Mask
Klarity Medical Products, LLC
RG460VHT
In Commercial Distribution

  • 00817355022065 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355022058

3.2mm AccuPerf White Versa Extended Head Mask
Klarity Medical Products, LLC
R461-5VHT
In Commercial Distribution

  • 00817355022058 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355022041

3.2mm 36% Perf White Versa Head Mask
Klarity Medical Products, LLC
R461VHT
In Commercial Distribution

  • 00817355022041 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355022034

2.4mm 36% Perf White Versa Head Mask
Klarity Medical Products, LLC
R460VHT
In Commercial Distribution

  • 00817355022034 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355022027

3.2mm 36% Perf White Versa Head/Shoulder Mask
Klarity Medical Products, LLC
R461VT
In Commercial Distribution

  • 00817355022027 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355022010

2.4mm 36% Perf White Versa Head/Shoulder Mask
Klarity Medical Products, LLC
R460VT
In Commercial Distribution

  • 00817355022010 ()


  • Patient positioning thermoplastic mould material

KLARITY MEDICAL - 00817355022003

Klarity White Thermoplastic Sheet 36% perforation, 1.6mm,610x460mm
Klarity Medical Products, LLC
P-1636A
In Commercial Distribution

  • 00817355022003 ()


  • Patient positioning thermoplastic mould material

KLARITY MEDICAL - 00817355021990

Klarity White Thermoplastic Sheet 12% perforation, 2.4mm, 610x460mm
Klarity Medical Products, LLC
P-2412A
In Commercial Distribution

  • 00817355021990 ()


  • Patient positioning thermoplastic mould material

KLARITY MEDICAL - 00817355021983

Klarity White Thermoplastic Sheet no perforation, 2.4mm, 610x460mm
Klarity Medical Products, LLC
P-2400A
In Commercial Distribution

  • 00817355021983 ()


  • Patient positioning thermoplastic mould material

KLARITY MEDICAL - 00817355021969

Klarity White Thermoplastic Sheet no perforation, 3.2mm, 610x460mm
Klarity Medical Products, LLC
P-3200A
In Commercial Distribution

  • 00817355021969 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355021945

Head and Shoulder Klarity Cushion for BOS Type Proton Boards
Klarity Medical Products, LLC
R550-BOS
In Commercial Distribution

  • 00817355021945 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355021921

Klarity Cushion
Klarity Medical Products, LLC
R550-CM2
In Commercial Distribution

  • 00817355021921 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355021914

Klarity Cushion
Klarity Medical Products, LLC
R550-CM1
In Commercial Distribution

  • 00817355021914 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355021891

Klarity PelvicFix Baseplate with Indexing, Carbon Fiber, for Klarity PelvicFix and Civco HipFix Masks
Klarity Medical Products, LLC
R606-ACF
In Commercial Distribution

  • 00817355021891 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355021785

Klarity Multifix Prone Tilting Head Support, Indexable, Acrylic
Klarity Medical Products, LLC
R609-HP
In Commercial Distribution

  • 00817355021785 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355021679

Green S-Type Head & Shoulder Mask AccuPerf™ 3.2mm
Klarity Medical Products, LLC
RG461-4ST
In Commercial Distribution

  • 00817355021679 ()


  • Patient positioning thermoplastic mould material

KLARITY MEDICAL - 00817355021006

Klarity White Thermoplastic Sheet no perforation, 3.2mm, 920x610mm
Klarity Medical Products, LLC
P-3200
In Commercial Distribution

  • 00817355021006 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355020894

Klarity Wedge Klarity Cushion™
Klarity Medical Products, LLC
R550-W1
In Commercial Distribution

  • 00817355020894 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355020887

Head & Shoulder Extended Klarity Cushion™ 45x51cm
Klarity Medical Products, LLC
R550-TL
In Commercial Distribution

  • 00817355020887 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355020870

Head & Shoulder Extended Klarity Cushion™ Plus 45x51 cm Added fill in the neck area, designed to be used without a headrest
Klarity Medical Products, LLC
R550-T2L
In Commercial Distribution

  • 00817355020870 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355020863

Head & Shoulder Klarity Cushion™ Plus 45x45 cm Added fill in the neck area, designed to be used without a headrest
Klarity Medical Products, LLC
R550-T2
In Commercial Distribution

  • 00817355020863 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355020856

Head & Shoulder Klarity Cushion™ 45x45cm
Klarity Medical Products, LLC
R550-T
In Commercial Distribution

  • 00817355020856 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355020849

15x25cm Klarity Cushion™
Klarity Medical Products, LLC
R550-S2T
In Commercial Distribution

  • 00817355020849 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355020832

15x25cm Klarity Cushion™
Klarity Medical Products, LLC
R550-S2
In Commercial Distribution

  • 00817355020832 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355020825

15x10cm Klarity Cushion™
Klarity Medical Products, LLC
R550-S1
In Commercial Distribution

  • 00817355020825 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355020818

15x20cm Klarity Cushion™
Klarity Medical Products, LLC
R550-S
In Commercial Distribution

  • 00817355020818 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355020801

Pediatric Head & Shoulder Klarity Cushion™ 30x45cm
Klarity Medical Products, LLC
R550-P
In Commercial Distribution

  • 00817355020801 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355020795

25x30cm Klarity Cushion™
Klarity Medical Products, LLC
R550-M1
In Commercial Distribution

  • 00817355020795 ()


  • Patient positioning thermoplastic mould material
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