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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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Tibial Tray, Size 3
Ascension Orthopedics, Inc.
LJU223T
In Commercial Distribution

LJU223T

  • Fixed-bearing total ankle prosthesis
Tibial Tray, Size 2
Ascension Orthopedics, Inc.
LJU222T
In Commercial Distribution

LJU222T

  • Fixed-bearing total ankle prosthesis
Tibial Tray, Size 1
Ascension Orthopedics, Inc.
LJU221T
In Commercial Distribution

LJU221T

  • Fixed-bearing total ankle prosthesis
Tibial Tray, Size 0
Ascension Orthopedics, Inc.
LJU220T
In Commercial Distribution

LJU220T

  • Fixed-bearing total ankle prosthesis
No Description
Freudenberg Medical, LLC
SP 1053
In Commercial Distribution



  • Nasal septal button
No Description
Freudenberg Medical, LLC
SP 1052
In Commercial Distribution



  • Nasal septal button
Bushing, Axle Standard Elbow
Howmedica Osteonics Corp.
C-MM100639-03
In Commercial Distribution

C-MM100639-03

  • Coated elbow humerus prosthesis
Axle Pin Assembly Large Elbow
Howmedica Osteonics Corp.
C-MM100639-04
In Commercial Distribution

C-MM100639-04

  • Coated elbow humerus prosthesis
40mm Distal Humeral component Modular Replacement Elbow
Howmedica Osteonics Corp.
C-MM100639-01
In Commercial Distribution

C-MM100639-01

  • Coated elbow humerus prosthesis
Stimulan® DS Calcium Sulfate Bone Void Filler is provided sterile for single patient use. The kit contains calcium sulfate powder and mixing solution in pre-measured quantities so that when mixed together, the resultant paste is to be injected or digitally packed into open bone/gap to cure insitu. The biodegradable, radiopaque mixture is resorbed in approximately 30-60 days when used in accordance with the device labelling. Stimulan® is manufactured from synthetic implant grade calcium sulfate dihydrate (CaS04, 2H20) that resporbs and is replaced with bone during the healing process. Also as the bone void filler is biodegradable and biocompatible; it may be used at an infected site.
BIOCOMPOSITES LTD
640-005
In Commercial Distribution


  • 5cc
640-005

  • Synthetic bone graft
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