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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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Luxisse - 00817724020609

YTTRIA STABILIZED ZIRCONIA, 1400 MPa BEND STRENGTH, 41% LIGHT TRANSMITTANCE
HEANY INDUSTRIES, INC.
0
In Commercial Distribution

  • 00817724020609 ()

  • Height: 22 Millimeter
  • Outer Diameter: 98 Millimeter
MDDK 3702HT22 T

  • Dental appliance fabrication material, ceramic

Luxisse - 00817724020593

YTTRIA STABILIZED ZIRCONIA, 1400 MPa BEND STRENGTH, 41% LIGHT TRANSMITTANCE
HEANY INDUSTRIES, INC.
0
In Commercial Distribution

  • 00817724020593 ()

  • Height: 20 Millimeter
  • Outer Diameter: 98 Millimeter
MDDK 3702HT20 T

  • Dental appliance fabrication material, ceramic

Luxisse - 00817724020586

YTTRIA STABILIZED ZIRCONIA, 1400 MPa BEND STRENGTH, 41% LIGHT TRANSMITTANCE
HEANY INDUSTRIES, INC.
0
In Commercial Distribution

  • 00817724020586 ()

  • Height: 18 Millimeter
  • Outer Diameter: 98 Millimeter
MDDK 3702HT18 T

  • Dental appliance fabrication material, ceramic

Luxisse - 00817724020579

YTTRIA STABILIZED ZIRCONIA, 1400 MPa BEND STRENGTH, 41% LIGHT TRANSMITTANCE
HEANY INDUSTRIES, INC.
0
In Commercial Distribution

  • 00817724020579 ()

  • Height: 16 Millimeter
  • Outer Diameter: 98 Millimeter
MDDK 3702HT16 T

  • Dental appliance fabrication material, ceramic

Luxisse - 00817724020562

YTTRIA STABILIZED ZIRCONIA, 1400 MPa BEND STRENGTH, 41% LIGHT TRANSMITTANCE
HEANY INDUSTRIES, INC.
0
In Commercial Distribution

  • 00817724020562 ()

  • Height: 14 Millimeter
  • Outer Diameter: 98 Millimeter
MDDK 3702HT14 T

  • Dental appliance fabrication material, ceramic

Luxisse - 00817724020555

YTTRIA STABILIZED ZIRCONIA, 1400 MPa BEND STRENGTH, 41% LIGHT TRANSMITTANCE
HEANY INDUSTRIES, INC.
0
In Commercial Distribution

  • 00817724020555 ()

  • Height: 12 Millimeter
  • Outer Diameter: 98 Millimeter
MDDK 3702HT12 T

  • Dental appliance fabrication material, ceramic

Luxisse - 00817724020531

YTTRIA STABILIZED ZIRCONIA. 1100 MPa BEND STRENGTH, 37% LIGHT TRANSMITTANCE
HEANY INDUSTRIES, INC.
0
In Commercial Distribution

  • 00817724020531 ()

  • Height: 20 Millimeter
  • Outer Diameter: 100 Millimeter
MDDK 3937ST20 P

  • Dental appliance fabrication material, ceramic

Luxisse - 00817724020524

YTTRIA STABILIZED ZIRCONIA. 1100 MPa BEND STRENGTH, 37% LIGHT TRANSMITTANCE
HEANY INDUSTRIES, INC.
0
In Commercial Distribution

  • 00817724020524 ()

  • Height: 18 Millimeter
  • Outer Diameter: 100 Millimeter
MDDK 3937ST18 P

  • Dental appliance fabrication material, ceramic

Luxisse - 00817724020517

YTTRIA STABILIZED ZIRCONIA. 1100 MPa BEND STRENGTH, 37% LIGHT TRANSMITTANCE
HEANY INDUSTRIES, INC.
0
In Commercial Distribution

  • 00817724020517 ()

  • Outer Diameter: 100 Millimeter
  • Height: 14 Millimeter
MDDK 3937ST14 P

  • Dental appliance fabrication material, ceramic

Walser® Plastoferm-Löffel F - 04262363910785

No Description
Dr. Walser Dental GmbH
0
Not in Commercial Distribution

  • 04262363910785 ()


  • Dental impression material kit, single-use

Walser® Plastoferm-Löffel L - 04262363910778

No Description
Dr. Walser Dental GmbH
0
Not in Commercial Distribution

  • 04262363910778 ()


  • Dental impression material kit, single-use

Walser® Injecto-Löffel - 04262363910761

No Description
Dr. Walser Dental GmbH
0
Not in Commercial Distribution

  • 04262363910761 ()


  • Dental impression material kit, single-use

Walser® MPI Löffel - 04262363910754

No Description
Dr. Walser Dental GmbH
0
Not in Commercial Distribution

  • 04262363910754 ()


  • Dental impression material kit, single-use

rematitan® - J011100205200

rematitan® milling blank Ti5 20 mm
DENTAURUM GmbH & Co.KG
0
In Commercial Distribution

  • J011100205200 ()
100-205-20

  • Dental casting non-noble alloy

rematitan® - J011100205150

rematitan® milling blank Ti5 15 mm
DENTAURUM GmbH & Co.KG
0
In Commercial Distribution

  • J011100205150 ()
100-205-15

  • Dental casting non-noble alloy

rematitan® - J011100205120

rematitan® milling blank Ti5 12 mm
DENTAURUM GmbH & Co.KG
0
In Commercial Distribution

  • J011100205120 ()
100-205-12

  • Dental casting non-noble alloy

rematitan® - J011100205100

rematitan® milling blank Ti5 10 mm
DENTAURUM GmbH & Co.KG
0
In Commercial Distribution

  • J011100205100 ()
100-205-10

  • Dental casting non-noble alloy

rematitan® - J011100202200

rematitan® milling blank Ti2 20 mm
DENTAURUM GmbH & Co.KG
0
In Commercial Distribution

  • J011100202200 ()
100-202-20

  • Dental casting non-noble alloy

rematitan® - J011100202150

rematitan® milling blank Ti2 15 mm
DENTAURUM GmbH & Co.KG
0
In Commercial Distribution

  • J011100202150 ()
100-202-15

  • Dental casting non-noble alloy

rematitan® - J011100202120

rematitan® milling blank Ti2 12 mm
DENTAURUM GmbH & Co.KG
0
In Commercial Distribution

  • J011100202120 ()
100-202-12

  • Dental casting non-noble alloy

rematitan® - J011100202100

rematitan® milling blank Ti2 10 mm
DENTAURUM GmbH & Co.KG
0
In Commercial Distribution

  • J011100202100 ()
100-202-10

  • Dental casting non-noble alloy

Cartilage Biopsy Transport Kit - 00860004093015

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

Skin Biopsy Transport Kit - 00860004093008

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

CLED Agar (Legacy 7122) - 00860003684696

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

Mueller Hinton Agar II - 00860003684634

(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

Mueller Hinton Agar II - 00860003684627

(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

Mueller Hinton Agar II - 00860003684610

(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

Mueller Hinton Agar II - 00860003684603

(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

Cartilage Biopsy Transport Kit - 00850037506194

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

  • 00850037506194 ()


  • Specimen container mailer, insulated
  • Cell culture medium IVD

KneeKG-Exoskeleton - 00627843933243

No Description
Emovi Inc
0
In Commercial Distribution

  • 00627843933243 ()
P-080

  • Gait analysis system

KneeKG system - 00627843933236

No Description
Emovi Inc
0
In Commercial Distribution

  • 00627843933236 ()
P-142

  • Gait analysis system

TECHFIT - 00860012759460

Maxilla Cutting Guide Ti
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860012759460 ()
GCMAXTI

  • Custom-made orthopaedic/craniofacial surgical guide

TECHFIT - 00860012759453

Mandible Cutting Guide Ti
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860012759453 ()
GCMANTI

  • Custom-made orthopaedic/craniofacial surgical guide

TECHFIT - 00860012759446

Fibula cutting guide Ti
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860012759446 ()
GCPTI

  • Custom-made orthopaedic/craniofacial surgical guide

TECHFIT - 00860012759439

Digitally Integrated Surgical Reconstruction Platform - DISRP
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860012759439 ()
DISRP

  • Custom-made orthopaedic/craniofacial surgical guide

TECHFIT - 00860012759422

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

  • 00860012759422 ()
FPCOD

  • Custom-made orthopaedic/craniofacial surgical guide

TECHFIT - 00860012759415

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

  • 00860012759415 ()
FICOD

  • Custom-made orthopaedic/craniofacial surgical guide

TECHFIT - 00860012759408

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

  • 00860012759408 ()
FFCOD

  • Custom-made orthopaedic/craniofacial surgical guide

TECHFIT - 00860011469285

Condyle Position Guide - Ti
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860011469285 ()
CGPTI

  • Custom-made orthopaedic/craniofacial surgical guide

TECHFIT - 00860011469261

BSSO Surgical Guide with Dental Support - TI
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860011469261 ()
GCSDTI

  • Custom-made orthopaedic/craniofacial surgical guide
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