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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TRUMATCH TI Implant - Midface Large
Materialise NV
SD980.105
In Commercial Distribution

  • 05420060381058 ()
SD980.105

  • Craniofacial fixation plate kit, non-bioabsorbable
TRUMATCH Midface/Mandible - Titanium 3D Printed Guide for Orbit
Materialise NV
SD980.104
In Commercial Distribution

  • 05420060381041 ()
SD980.104

  • Custom-made orthopaedic/craniofacial surgical guide
TRUMATCH Midface/Mandible - Titanium 3D Printed Implant for Orbit
Materialise NV
SD980.103
In Commercial Distribution

  • 05420060381034 ()
SD980.103

  • Custom-made orthopaedic/craniofacial surgical guide
Midface Reconstruction kit
Materialise NV
SD980.032
In Commercial Distribution

  • 05420060380761 ()
SD980.032

  • Custom-made organ/bone anatomy model/surgical guide kit
Mandible Reconstruction kit
Materialise NV
SD980.031
In Commercial Distribution

  • 05420060380754 ()
SD980.031

  • Custom-made organ/bone anatomy model/surgical guide kit
Titanium 3D Printed Guide, Bone harvesting
Materialise NV
SD980.028
In Commercial Distribution

  • 05420060380747 ()
SD980.028

  • Custom-made orthopaedic/craniofacial surgical guide
TRUMATCH Midface/Mandible - Titanium 3D Printed Plate for Mandible, Large
Materialise NV
SD980.021
In Commercial Distribution

  • 05420060380211 ()
SD980.021

  • Custom-made cranial bone prosthesis
TRUMATCH Midface/Mandible - Titanium 3D Printed Plate for Mandible, Medium
Materialise NV
SD980.020
In Commercial Distribution

  • 05420060380204 ()
SD980.020

  • Custom-made cranial bone prosthesis
TRUMATCH Midface/Mandible - Titanium 3D Printed Plate for Mandible, Small
Materialise NV
SD980.019
In Commercial Distribution

  • 05420060380198 ()
SD980.019

  • Custom-made cranial bone prosthesis
TRUMATCH Midface/Mandible - Zygomatic Surgical Kit
Materialise NV
SD980.018
In Commercial Distribution

  • 05420060380181 ()
SD980.018

  • Craniofacial fixation plate kit, non-bioabsorbable
TRUMATCH Midface/Mandible - Titanium 3D Printed Guide for Mandible
Materialise NV
SD980.017
In Commercial Distribution

  • 05420060380174 ()
SD980.017

  • Custom-made orthopaedic/craniofacial surgical guide
TRUMATCH Midface/Mandible - Titanium 3D Printed Plate for Mandible, Mini
Materialise NV
SD980.016
In Commercial Distribution

  • 05420060380167 ()
SD980.016

  • Custom-made cranial bone prosthesis
TRUMATCH Midface/Mandible - Titanium 3D Printed Guide for Midface
Materialise NV
SD980.015
In Commercial Distribution

  • 05420060380150 ()
SD980.015

  • Custom-made orthopaedic/craniofacial surgical guide
TRUMATCH Midface/Mandible - Titanium 3D Printed Plate for Midface
Materialise NV
SD980.014
In Commercial Distribution

  • 05420060380143 ()
SD980.014

  • Custom-made cranial bone prosthesis
TTRUMATCH Orthognathics - Genioplasty Surgical Kit, Add-on
Materialise NV
SD980.013
In Commercial Distribution

  • 05420060380136 ()
SD980.013

  • Craniofacial fixation plate kit, non-bioabsorbable
TRUMATCH Orthognathics - Basic Mandibular Surgical Kit, without Planning
Materialise NV
SD980.012
In Commercial Distribution

  • 05420060380129 ()
SD980.012

  • Craniofacial fixation plate kit, non-bioabsorbable
TRUMATCH Orthognathics - Basic Mandibular Surgical Kit
Materialise NV
SD980.011
In Commercial Distribution

  • 05420060380112 ()
SD980.011

  • Craniofacial fixation plate kit, non-bioabsorbable
TRUMATCH Orthognathics - Full Mandibular Surgical Kit, without planning
Materialise NV
SD980.010
In Commercial Distribution

  • 05420060380105 ()
SD980.010

  • Craniofacial fixation plate kit, non-bioabsorbable
Patient Specific Instrument and Planning Kit, Orthognathic Kit, one Splint
Materialise NV
SD900.009
Not in Commercial Distribution

  • 05420060350092 ()
SD900.009

  • Custom-made organ/bone anatomy model/surgical guide kit
Patient Specific Instrument and Planning Kit, Orthognathic Kit, two Splints
Materialise NV
SD900.008
Not in Commercial Distribution

  • 05420060350085 ()
SD900.008

  • Custom-made organ/bone anatomy model/surgical guide kit
Patient Specific Instrument and Planning Kit, Distraction
Materialise NV
SD900.006
In Commercial Distribution

  • 05420060350061 ()
SD900.006

  • Custom-made organ/bone anatomy model/surgical guide kit
Patient Specific Instrument and Planning Kit, Midface Reconstruction
Materialise NV
SD900.004
In Commercial Distribution

  • 05420060350047 ()
SD900.004

  • Custom-made organ/bone anatomy model/surgical guide kit
Patient Specific Instrument and Planning Kit, Basic Mandible Reconstruction
Materialise NV
SD900.003
In Commercial Distribution

  • 05420060350030 ()
SD900.003

  • Custom-made organ/bone anatomy model/surgical guide kit
Patient Specific Instrument and Planning Kit, Mandible Reconstruction
Materialise NV
SD900.001
In Commercial Distribution

  • 05420060350016 ()
SD900.001

  • Custom-made organ/bone anatomy model/surgical guide kit
Heartprint medical model, SLS
Materialise NV
HEAPR-01-001-01
In Commercial Distribution

  • 05420060346019 ()
HEAPR-01-001-01

  • Custom-made organ/bone anatomy model
Heartprint medical model, SLA
Materialise NV
HEAPR-01-002-01
In Commercial Distribution

  • 05420060346002 ()
HEAPR-01-002-01

  • Custom-made organ/bone anatomy model
Lower extremity Guide and Model
Materialise NV
O-01-0-300000-0021-020
In Commercial Distribution

  • 05420060343407 ()
O-01-0-300000-0021-020

  • Custom-made organ/bone anatomy model/surgical guide kit
TRULIFE NATURAL KNEE WITH PYRAMID AND MANUAL LOCK
TRULIFE LIMITED
SSK602L
In Commercial Distribution

  • 00645517842158 ()


  • Knee support orthosis
Matrix Max Raw AFO (One Size Right)
TRULIFE LIMITED
FH225-R
In Commercial Distribution

  • 00645517800240 ()


  • Ankle/foot orthosis
Matrix Max Raw AFO (One Size Left)
TRULIFE LIMITED
FH225-L
In Commercial Distribution

  • 00645517800233 ()


  • Ankle/foot orthosis
REPLACEMENT LAMINATING BRACKET FOR SSK610A
TRULIFE LIMITED
SSK610A-DIS
In Commercial Distribution

  • 00645517800196 ()


  • Knee support orthosis
TRULIFE CHILDS PLAY LOCKING KNEE
TRULIFE LIMITED
SSK610A
In Commercial Distribution

  • 00645517800103 ()


  • Knee support orthosis
ALEXANDRA SANDSTONE FULL COVERAGE SEAMLESS MOLDED MASTECTOMY BRA SS4013DD38
Trulife Limited
SS4013DD38
In Commercial Distribution

  • 00645517721385 ()


  • Postsurgical brassiere, non-antimicrobial
ALEXANDRA SANDSTONE FULL COVERAGE SEAMLESS MOLDED MASTECTOMY BRA SS4013DD36
Trulife Limited
SS4013DD36
In Commercial Distribution

  • 00645517721361 ()


  • Postsurgical brassiere, non-antimicrobial
ALEXANDRA SANDSTONE FULL COVERAGE SEAMLESS MOLDED MASTECTOMY BRA SS4013DD34
Trulife Limited
SS4013DD34
In Commercial Distribution

  • 00645517721347 ()


  • Postsurgical brassiere, non-antimicrobial
ALEXANDRA SANDSTONE FULL COVERAGE SEAMLESS MOLDED MASTECTOMY BRA SS4013D40
Trulife Limited
SS4013D40
In Commercial Distribution

  • 00645517721323 ()


  • Postsurgical brassiere, non-antimicrobial
ALEXANDRA SANDSTONE FULL COVERAGE SEAMLESS MOLDED MASTECTOMY BRA SS4013D38
Trulife Limited
SS4013D38
In Commercial Distribution

  • 00645517721309 ()


  • Postsurgical brassiere, non-antimicrobial
ALEXANDRA SANDSTONE FULL COVERAGE SEAMLESS MOLDED MASTECTOMY BRA SS4013D36
Trulife Limited
SS4013D36
In Commercial Distribution

  • 00645517721286 ()


  • Postsurgical brassiere, non-antimicrobial
ALEXANDRA SANDSTONE FULL COVERAGE SEAMLESS MOLDED MASTECTOMY BRA SS4013D34
Trulife Limited
SS4013D34
In Commercial Distribution

  • 00645517721262 ()


  • Postsurgical brassiere, non-antimicrobial
ALEXANDRA SANDSTONE FULL COVERAGE SEAMLESS MOLDED MASTECTOMY BRA SS4013C42
Trulife Limited
SS4013C42
In Commercial Distribution

  • 00645517721248 ()


  • Postsurgical brassiere, non-antimicrobial
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