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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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The brace is composed of a low-temperature thermoplastic fused between a layers of 3D stretchable knitted fabric and a layers of 3D stretchable knitted velcro receptive fabric. The brace can be molded directly to the patient to immobilize a wrist, with the ability to be remolded to follow the patient's change in morphology (loss of swelling), evolution in a treatment (tendon stretching), correction of deformities, or other reason in accordance with the treatment procedure for a specific patient. This is a multiple use single patient brace. Velcro closure separate. Size small (01), medium (02), or large (03), Adult (ADU)
9321-8758 Québec Inc
Wrist Adult
In Commercial Distribution

  • 30628634832159 ()

  • ADU S for Adult Small
  • ADU M for Adult Medium
  • ADU L for Adult Large
HBPA-01, HBPA-02,HBPA-03

  • Custom-made upper-limb orthosis
The brace is composed of a low-temperature thermoplastic fused between layers of 3D stretchable knitted fabric. The brace can be molded directly to the patient to immobilize a wrist, with the ability to be remolded to follow the patient's change in morphology (loss of swelling), evolution in a treatment (tendon stretching), correction of deformities, or other reason in accordance with the treatment procedure for a specific patient. This is a multiple use single patient brace with velcro closure. Size small (01), medium (02), or large (03), Adult (ADU)
9321-8758 Québec Inc
Wrist Adult with velcro closure
In Commercial Distribution

  • 30628634832104 ()

  • ADU S for Adult Small
  • ADU M for Adult Medium
  • ADU L for Adult Large
TBPAV-01, TBPAV-02,TBPAV-03

  • Custom-made upper-limb orthosis
The brace is composed of a low-temperature thermoplastic fused between layers of 3D stretchable knitted fabric. The brace can be molded directly to the patient to immobilize a wrist, with the ability to be remolded to follow the patient's change in morphology (loss of swelling), evolution in a treatment (tendon stretching), correction of deformities, or other reason in accordance with the treatment procedure for a specific patient. This is a multiple use single patient brace with zipper closure. Size small (01), medium (02), or large (03), Adult (ADU)
9321-8758 Québec Inc
Wrist Adult with zipper closure
In Commercial Distribution

  • 30628634832098 ()

  • ADU S for Adult Small
  • ADU M for Adult Medium
  • ADU L for Adult Large
TBPAZ-01, TBPAZ-02,TBPAZ-03

  • Custom-made upper-limb orthosis
The brace is composed of a low-temperature thermoplastic fused between layers of 3D stretchable knitted fabric. The brace can be molded directly to the patient to immobilize an ankle, with the ability to be remolded to follow the patient's change in morphology (loss of swelling), evolution in a treatment (tendon stretching for toe walkers), correction of deformities, or other reason in accordance with the treatment procedure for a specific patient. This is a multiple use single patient brace. Size small (01), medium (02), or large (03), Adult (ADU)
9321-8758 Québec Inc
Ankle Adult Reinforced
In Commercial Distribution

  • 30628634832067 ()

  • ADU S for adult small
  • ADU M for adult medium
  • ADU L for adult large
TBCAR-01, TBCAR-02, TBCAR-03

  • Custom-made lower-limb orthosis
The brace is composed of a low-temperature thermoplastic fused between layers of 3D stretchable knitted fabric. The brace can be molded directly to the patient to immobilize an ankle, with the ability to be remolded to follow the patient's change in morphology (loss of swelling), evolution in a treatment (tendon stretching for toe walkers), correction of deformities, or other reason in accordance with the treatment procedure for a specific patient. This is a multiple use single patient brace. Size small (01), medium (02), or large (03), Adult (ADU)
9321-8758 Québec Inc
Ankle Adult
In Commercial Distribution

  • 30628634832050 ()

  • ADU S for adult small
  • ADU M for adult medium
  • ADU L for adult large
TBCA-01, TBCA-02, TBCA-03

  • Custom-made lower-limb orthosis
Light Green Head Mask 2.4mm, Perf 12% for Elekta HeadSTEP™ System
Klarity Medical Products, LLC
RLG-ELH-2412C
In Commercial Distribution

  • 00817355023901 ()


  • Patient positioning thermoplastic mould material
Klarity Green IMRT Open Face Profile Frame Head Mask 3.2mm, AccuPerf (Reinforced) Extended Neckline
Klarity Medical Products, LLC
RG464-81W
In Commercial Distribution

  • 00817355023826 ()


  • Patient positioning thermoplastic mould material
Klarity Reloadable Head Mask 3.2mm, 9x10" Perf 42% for S-Type
Klarity Medical Products, LLC
R471SH
In Commercial Distribution

  • 00817355023802 ()


  • Patient positioning thermoplastic mould material
PelvicFix™ Bodycast with disposable frame solid 3.2mm, 46x56cm
Klarity Medical Products, LLC
R902-7A
In Commercial Distribution

  • 00817355023765 ()


  • Patient positioning thermoplastic mould material
PelvicFix™ Bodycast with disposable frame with 42% perforation 3.2mm, 46x56cm
Klarity Medical Products, LLC
R902-3A
In Commercial Distribution

  • 00817355023758 ()


  • Patient positioning thermoplastic mould material
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