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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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Interm Orthog Surgical Splint Digital
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860012759415 ()
FICOD

  • Custom-made orthopaedic/craniofacial surgical guide
Final Orthog Surgical Splint Digital
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860012759408 ()
FFCOD

  • Custom-made orthopaedic/craniofacial surgical guide
Fibula cutting guide Ti
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860012759446 ()
GCPTI

  • Custom-made orthopaedic/craniofacial surgical guide
Palatal Orthog Surgical Splint Digital
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860012759422 ()
FPCOD

  • Custom-made orthopaedic/craniofacial surgical guide
a calculator/data processing module for clinical use described as electronic device intended to store, retrieve, and process laboratory data.
ASSOCIATES OF CAPE COD, INC.
0
In Commercial Distribution

  • 00862696000289 ()


  • Laboratory instrument/analyser application software IVD
No Description
ELECTRO MEDICAL TECHNOLOGIES, LLC
0
In Commercial Distribution

  • 00861284002636 ()


  • Transcutaneous electrical stimulation electrode, single-use
No Description
ELECTRO MEDICAL TECHNOLOGIES, LLC
0
In Commercial Distribution

  • 00861284002612 ()


  • Transcutaneous electrical stimulation electrode, single-use
Le Fort Surgical Guide - Wall with Splints - Resin
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860007543494 ()
GCLPFBC

  • Custom-made orthopaedic/craniofacial surgical guide
Le Fort Surgical Guide - Slots with Splints - Resin
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860007543487 ()
GCLRFBC

  • Custom-made orthopaedic/craniofacial surgical guide
Le Fort Surgical Guide - Wall Resin
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860007543470 ()
GCLPBC

  • Custom-made orthopaedic/craniofacial surgical guide
Le Fort Surgical Guide - Slots Resin
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860007543463 ()
GCLRBC

  • Custom-made orthopaedic/craniofacial surgical guide
Final Orthognathic Surgical Splint
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860007543456 ()
FFCOBC

  • Custom-made orthopaedic/craniofacial surgical guide
Intermediate Orhognathic Surgical Splint
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860007543449 ()
FICOBC

  • Custom-made orthopaedic/craniofacial surgical guide
Maxillomandibular Anatomic Diagnostic Model CL
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860007543432 ()
MAPMMCL

  • Custom-made organ/bone anatomy model
Patient-Specific Maxillofacial/midface implant-Ti
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860007543425 ()
BETMCT

  • Custom-made cranial bone prosthesis
Patient-Specific Maxillary Implant - Titanium - high complexity
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860007543418 ()
BEACMXT

  • Custom-made cranial bone prosthesis
Patient-Specific Mandible Implant - Titanium - high complexity
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860007543401 ()
BEACMT

  • Custom-made cranial bone prosthesis
The Cartilage Biopsy Transport Kit, developed by Vericel Corporation, provides a way for surgeons to preserve a live cartilage biopsy and return it to the Vericel Cambridge Manufacturing Facility for the production of MACI - (Container, specimen mailer and storage, temperature controlled, sterile)
VERICEL CORPORATION
0
In Commercial Distribution

  • 00860004093015 ()


  • Specimen container mailer, insulated
  • Cell culture medium IVD
The Skin Biopsy Transport Kit, developed by Vericel Corporation, provides a way for surgeons to preserve a live skin biopsy and return it to the Vericel Cambridge Manufacturing Facility for the production of EPICEL - (Container, specimen mailer and storage, temperature controlled, sterile)
VERICEL CORPORATION
0
In Commercial Distribution

  • 00860004093008 ()


  • Specimen container mailer, insulated
  • Cell culture medium IVD
Cystine Lactose Electrolyte Deficient (CLED) Agar is used for the differentiation and enumeration of microorganisms in urine.
NEOGEN CORPORATION
0
In Commercial Distribution

  • 00860003684696 ()
NCM0256

  • Differential/selective agar culture medium IVD
(Conforms to CLSI) For use in antimicrobial susceptibility testing by the disk diffusion method.
NEOGEN CORPORATION
0
In Commercial Distribution

  • 00860003684634 ()
NCM0023E

  • Mueller-Hinton agar antimicrobial susceptibility culture medium IVD
(Conforms to CLSI) For use in antimicrobial susceptibility testing by the disk diffusion method.
NEOGEN CORPORATION
0
In Commercial Distribution

  • 00860003684627 ()
NCM0023C

  • Mueller-Hinton agar antimicrobial susceptibility culture medium IVD
(Conforms to CLSI) For use in antimicrobial susceptibility testing by the disk diffusion method.
NEOGEN CORPORATION
0
In Commercial Distribution

  • 00860003684610 ()
NCM0023B

  • Mueller-Hinton agar antimicrobial susceptibility culture medium IVD
(Conforms to CLSI) For use in antimicrobial susceptibility testing by the disk diffusion method.
NEOGEN CORPORATION
0
In Commercial Distribution

  • 00860003684603 ()
NCM0023A

  • Mueller-Hinton agar antimicrobial susceptibility culture medium IVD
Modified Wright-Giemsa Stain Pack
Cardinal Health 200, LLC
0
In Commercial Distribution

  • 50885380152298 ()
  • 10885380152290 ()
CHB3005

  • Laboratory Y-piece connector
Modified Wright Stain Pack
Cardinal Health 200, LLC
0
In Commercial Distribution

  • 50885380152281 ()
  • 10885380152283 ()
CHB3000

  • Laboratory Y-piece connector
The Skin Biopsy Transport Kit, developed by Vericel Corporation, provides a way for surgeons to preserve a live skin biopsy and return it to the Vericel Cambridge Manufacturing Facility for the production of EPICEL - (Container, specimen mailer and storage, temperature controlled, sterile)
VERICEL CORPORATION
0
In Commercial Distribution

  • 10850037506207 ()


  • Specimen container mailer, insulated
  • Cell culture medium IVD
BEAM SCREW - 22MM
MCGINLEY ORTHOPAEDIC INNOVATIONS, LLC
0
In Commercial Distribution

  • B666MCGS220 ()
MCG-S22

  • Orthopaedic bone screw (non-sliding)
BEAM SCREW - 21MM
MCGINLEY ORTHOPAEDIC INNOVATIONS, LLC
0
In Commercial Distribution

  • B666MCGS210 ()
MCG-S21

  • Orthopaedic bone screw (non-sliding)
BEAM SCREW - 20MM
MCGINLEY ORTHOPAEDIC INNOVATIONS, LLC
0
In Commercial Distribution

  • B666MCGS200 ()
MCG-S20

  • Orthopaedic bone screw (non-sliding)
BEAM SCREW - 19MM
MCGINLEY ORTHOPAEDIC INNOVATIONS, LLC
0
In Commercial Distribution

  • B666MCGS190 ()
MCG-S19

  • Orthopaedic bone screw (non-sliding)
BEAM SCREW - 18MM
MCGINLEY ORTHOPAEDIC INNOVATIONS, LLC
0
In Commercial Distribution

  • B666MCGS180 ()
MCG-S18

  • Orthopaedic bone screw (non-sliding)
BEAM SCREW - 17MM
MCGINLEY ORTHOPAEDIC INNOVATIONS, LLC
0
In Commercial Distribution

  • B666MCGS170 ()
MCG-S17

  • Orthopaedic bone screw (non-sliding)
BEAM SCREW – 15MM
MCGINLEY ORTHOPAEDIC INNOVATIONS, LLC
0
In Commercial Distribution

  • B666MCGS150 ()
MCG-S15

  • Orthopaedic bone screw (non-sliding)
BEAM SCREW - 13MM
MCGINLEY ORTHOPAEDIC INNOVATIONS, LLC
0
In Commercial Distribution

  • B666MCGS130 ()
MCG-S13

  • Orthopaedic bone screw (non-sliding)
RIGHT PLATE, SMALL, WIDE, 2 BEAMS, VARIABLE
MCGINLEY ORTHOPAEDIC INNOVATIONS, LLC
0
In Commercial Distribution

  • B666MCGRF2V0 ()
MCG-RF2V

  • Orthopaedic fixation plate, non-bioabsorbable
RIGHT PLATE, SMALL, WIDE, 1 BEAM, FIXED
MCGINLEY ORTHOPAEDIC INNOVATIONS, LLC
0
In Commercial Distribution

  • B666MCGRF1F0 ()
MCG-RF1F

  • Orthopaedic fixation plate, non-bioabsorbable
Plates MCG-RE2V AND MCG-RF2V GUIDE BLOCK
MCGINLEY ORTHOPAEDIC INNOVATIONS, LLC
0
In Commercial Distribution

  • B666MCGREF2VG0 ()
MCG-REF2VG

  • General internal orthopaedic fixation system implantation kit
Plates MCG-RE1F AND MCG-RF1F GUIDE BLOCK
MCGINLEY ORTHOPAEDIC INNOVATIONS, LLC
0
In Commercial Distribution

  • B666MCGREF1FG0 ()
MCG-REF1FG

  • General internal orthopaedic fixation system implantation kit
RIGHT PLATE, EXTRA SMALL, WIDE, 1 BEAM, FIXED
MCGINLEY ORTHOPAEDIC INNOVATIONS, LLC
0
In Commercial Distribution

  • B666MCGRE1F0 ()
MCG-RE1F

  • Orthopaedic fixation plate, non-bioabsorbable
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