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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 - 00817355020788

20x25cm Klarity Cushion™
Klarity Medical Products, LLC
R550-M
In Commercial Distribution

  • 00817355020788 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355020771

45x60 cm Klarity Cushion™
Klarity Medical Products, LLC
R550-L2
In Commercial Distribution

  • 00817355020771 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355020764

20x25cm AccuCushion™
Klarity Medical Products, LLC
R550-L
In Commercial Distribution

  • 00817355020764 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355020757

Head & Shoulder Extended Shell Cushion-Plus™ with added fill in the neck area 45x56 cm Designed to be used without a headrest
Klarity Medical Products, LLC
R550-HS2L
In Commercial Distribution

  • 00817355020757 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355020740

Head & Shoulder Extended Shell Klarity Cushion™ 45x56 cm
Klarity Medical Products, LLC
R550-HS1L
In Commercial Distribution

  • 00817355020740 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355020733

Head & Shoulder Shell Cushion-Plus™ with added fill in the neck area 45x50 cm Designed to be used without a headrest
Klarity Medical Products, LLC
R550-HS2
In Commercial Distribution

  • 00817355020733 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355020726

Head & Shoulder Shell Cushion™ 45x50 cm
Klarity Medical Products, LLC
R550-HS1
In Commercial Distribution

  • 00817355020726 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355020719

Head Only Shell Klarity Cushion™ 26x35 cm
Klarity Medical Products, LLC
R550-H1
In Commercial Distribution

  • 00817355020719 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355020702

White 4-Point O-Type Pelvic Mask 42% perforation 3.2mm 46.3x48cm
Klarity Medical Products, LLC
RD901-3242
In Commercial Distribution

  • 00817355020702 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355020696

Green O-Type 3-Point Pediatric Head Mask 36% perforation 2.4mm
Klarity Medical Products, LLC
RDG104-2436
In Commercial Distribution

  • 00817355020696 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355020689

Green O-Type 3-Point Head Mask (with nosehole) AccuPerf™ 2.4mm
Klarity Medical Products, LLC
RDG105-24A
In Commercial Distribution

  • 00817355020689 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355020672

Green O-Type 3-Point Head Mask (with nosehole) AccuPerf™ 3.2mm
Klarity Medical Products, LLC
RDG105-32A
In Commercial Distribution

  • 00817355020672 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355020665

Light Green O-Type 3-Point Head Mask (with nosehole) 12% perforation 2.4mm
Klarity Medical Products, LLC
RDG105-2412C
In Commercial Distribution

  • 00817355020665 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355020658

Green O-Type 3-Point Rounded Head Mask (with nosehole) AccuPerf™ 2.4mm
Klarity Medical Products, LLC
RDG107-24A
In Commercial Distribution

  • 00817355020658 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355020641

Green O-Type 3-Point Rounded Head Mask (with nosehole) AccuPerf™ 3.2mm
Klarity Medical Products, LLC
RDG107-32A
In Commercial Distribution

  • 00817355020641 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355020634

Klarity Green O-Type Head Mask 3.2mm, 42% Perforation, 3 Point, Rounded Neckline, With Nose Hole, for Klarity and Orfit Baseplates
Klarity Medical Products, LLC
RDG107-3242N
In Commercial Distribution

  • 00817355020634 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355020627

Green O-Type 5-Point Pediatric Head & Shoulder Mask 36% perforation 2.4mm
Klarity Medical Products, LLC
RDG204-2436
In Commercial Distribution

  • 00817355020627 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355020610

Green O-Type 5-Point Head & Shoulder Mask (with nosehole) AccuPerf™ 2.4mm
Klarity Medical Products, LLC
RDG207-24A
In Commercial Distribution

  • 00817355020610 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355020603

Green O-Type 5-Point Head & Shoulder Mask (with nosehole) AccuPerf™ 3.2mm
Klarity Medical Products, LLC
RDG207-32A
In Commercial Distribution

  • 00817355020603 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355020597

Klarity Green O-Type Head and Shoulder Mask 3.2mm, 42% Perforation, 5 Point, With Nose Hole, for Klarity and Orfit Baseplates
Klarity Medical Products, LLC
RDG207-3242N
In Commercial Distribution

  • 00817355020597 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355020580

Light Green O-Type 5-Point Head & Shoulder Mask (with nosehole) 12% perforation 2.4mm
Klarity Medical Products, LLC
RDG207-2412C
In Commercial Distribution

  • 00817355020580 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355020573

Green Large BoS Head & Shoulder Mask 42% perforation 3.2mm 48cm wide
Klarity Medical Products, LLC
RG-BSL-3242
In Commercial Distribution

  • 00817355020573 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355020566

Klarity Green Head Mask for BOS, 3.2mm, 42% Perforation, Large (38cm wide) Compatible with Qfix BOS Baseplates
Klarity Medical Products, LLC
RG-BHL-3242
In Commercial Distribution

  • 00817355020566 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355020559

Green Medium BoS Head Mask 42% perforation 3.2mm 31cm wide
Klarity Medical Products, LLC
RG-BHM-3242
In Commercial Distribution

  • 00817355020559 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355020542

Green Medium BoS Head Mask with Flap 42% perforation 3.2mm 31cm wide
Klarity Medical Products, LLC
RG-BHM-3242F
In Commercial Distribution

  • 00817355020542 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355020535

Green Small BoS Head Mask 42% perforation 3.2mm 26cm wide
Klarity Medical Products, LLC
RG-BHS-3242
In Commercial Distribution

  • 00817355020535 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355020528

Klarity Green Head & Shoulder Mask for BOS, 2.4mm 36% Perforation, Large (48cm Wide) Compatible with Qfix BOS Baseplates
Klarity Medical Products, LLC
RG-BSL-2436
In Commercial Distribution

  • 00817355020528 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355020511

Klarity Green Head Mask for BOS, 2.4mm, 36% Perforation, Large (38cm wide) Compatible with Qfix BOS Baseplates
Klarity Medical Products, LLC
RG-BHL-2436
In Commercial Distribution

  • 00817355020511 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355020498

Klarity Green Head Mask for BOS, 2.4mm 36% Perforation, Medium (31cm wide) Compatible with Qfix BOS Baseplates
Klarity Medical Products, LLC
RG-BHM-2436
In Commercial Distribution

  • 00817355020498 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355020481

Klarity Green Head Mask for BOS, 2.4mm 36% Perforation, Small (26cm Wide) Compatible with Qfix BOS Baseplates
Klarity Medical Products, LLC
RG-BHS-2436
In Commercial Distribution

  • 00817355020481 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355020474

Klarity Green Head Mask for BOS, 2.0mm 15% Perforation, Medium (31cm wide) Compatible with Qfix BOS Baseplates
Klarity Medical Products, LLC
RG-BHM-2015
In Commercial Distribution

  • 00817355020474 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355020467

Green Stereotactic Head Frame Mask Set Type B
Klarity Medical Products, LLC
RG408-4AC
In Commercial Distribution

  • 00817355020467 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355020450

White Stereotactic Head & Shoulder Frame Mask Set Type B
Klarity Medical Products, LLC
R408-2
In Commercial Distribution

  • 00817355020450 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355020443

White Stereotactic Head Frame Mask Set Type B
Klarity Medical Products, LLC
R408
In Commercial Distribution

  • 00817355020443 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355020436

White Stereotactic Head Frame Mask Set Type A
Klarity Medical Products, LLC
R406-1
In Commercial Distribution

  • 00817355020436 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355020429

Green ProfileFrame™ Extended Head Mask AccuPerf™ 3.2mm
Klarity Medical Products, LLC
RG464-1W
In Commercial Distribution

  • 00817355020429 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355020412

Green ProfileFrame™ Extended Head Mask 42% perforation 3.2mm
Klarity Medical Products, LLC
RG431W
In Commercial Distribution

  • 00817355020412 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355020405

Green U-Max™ WideFace Extended Head Mask 42% perforation 3.2mm
Klarity Medical Products, LLC
RG431E
In Commercial Distribution

  • 00817355020405 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355020399

Green ProfileFrame™ Head Mask AccuPerf™ 3.2mm
Klarity Medical Products, LLC
RG430-1W
In Commercial Distribution

  • 00817355020399 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355020382

Green ProfileFrame™ Head Mask 42% perforation 3.2mm
Klarity Medical Products, LLC
RG430W
In Commercial Distribution

  • 00817355020382 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355020375

Green U-Max™ WideFace Head Mask 42% perforation 3.2mm
Klarity Medical Products, LLC
RG430E
In Commercial Distribution

  • 00817355020375 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355020368

Green ProfileFrame™ Extended Head Mask 36% perforation 2.4mm
Klarity Medical Products, LLC
RG421W
In Commercial Distribution

  • 00817355020368 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355020351

Green U-Max™ WideFace Extended Head Mask 36% perforation 2.4mm
Klarity Medical Products, LLC
RG421E
In Commercial Distribution

  • 00817355020351 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355020344

Green ProfileFrame™ Head Mask AccuPerf™ 2.4mm
Klarity Medical Products, LLC
RG420-1W
In Commercial Distribution

  • 00817355020344 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355020337

Green ProfileFrame™ Head Mask 36% perforation 2.4mm
Klarity Medical Products, LLC
RG420W
In Commercial Distribution

  • 00817355020337 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355020320

Klarity Green U-Max Head Mask 2.4mm 10"x10" 36% Perforation U-Frame Mask
Klarity Medical Products, LLC
RG420E
In Commercial Distribution

  • 00817355020320 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355020313

Klarity White Reloadable Head Mask 2.4mm, 36% Perforation S-Type Mask for Civco boards
Klarity Medical Products, LLC
R470SH
In Commercial Distribution

  • 00817355020313 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355020306

White ProfileFrame™ Extended Head Mask AccuPerf™ 3.2mm
Klarity Medical Products, LLC
R464-1W
In Commercial Distribution

  • 00817355020306 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355020290

Klarity ContourFrame™ Head Mask Contour perforation 2.4mm
Klarity Medical Products, LLC
R450U
In Commercial Distribution

  • 00817355020290 ()


  • Patient positioning thermoplastic mould material

Klarity Medical - 00817355020283

White ProfileFrame™ Extended Head Mask 42% perforation 3.2mm
Klarity Medical Products, LLC
R431W
In Commercial Distribution

  • 00817355020283 ()


  • Patient positioning thermoplastic mould material
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