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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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Genioplasty Surgical Guide with dental support - Ti
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860010801642 ()
GCGSDTI

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

  • 00860010801635 ()
GCLTI

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

  • 00860010801628 ()
GCLSDTI

  • Custom-made orthopaedic/craniofacial surgical guide
Genioplasty Surgical Guide with Splint - Resin
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860010801611 ()
GCGFBC

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

  • 00860010801604 ()
GCGBC

  • Custom-made orthopaedic/craniofacial surgical guide
rematitan® milling blank Ti5 20 mm
DENTAURUM GmbH & Co.KG
0
In Commercial Distribution

  • J011100205200 ()
100-205-20

  • Dental casting non-noble alloy
rematitan® milling blank Ti5 15 mm
DENTAURUM GmbH & Co.KG
0
In Commercial Distribution

  • J011100205150 ()
100-205-15

  • Dental casting non-noble alloy
rematitan® milling blank Ti5 12 mm
DENTAURUM GmbH & Co.KG
0
In Commercial Distribution

  • J011100205120 ()
100-205-12

  • Dental casting non-noble alloy
rematitan® milling blank Ti5 10 mm
DENTAURUM GmbH & Co.KG
0
In Commercial Distribution

  • J011100205100 ()
100-205-10

  • Dental casting non-noble alloy
rematitan® milling blank Ti2 20 mm
DENTAURUM GmbH & Co.KG
0
In Commercial Distribution

  • J011100202200 ()
100-202-20

  • Dental casting non-noble alloy
rematitan® milling blank Ti2 15 mm
DENTAURUM GmbH & Co.KG
0
In Commercial Distribution

  • J011100202150 ()
100-202-15

  • Dental casting non-noble alloy
rematitan® milling blank Ti2 12 mm
DENTAURUM GmbH & Co.KG
0
In Commercial Distribution

  • J011100202120 ()
100-202-12

  • Dental casting non-noble alloy
rematitan® milling blank Ti2 10 mm
DENTAURUM GmbH & Co.KG
0
In Commercial Distribution

  • J011100202100 ()
100-202-10

  • Dental casting non-noble alloy
No Description
Emovi Inc
0
In Commercial Distribution

  • 00627843933243 ()
P-080

  • Gait analysis system
No Description
Emovi Inc
0
In Commercial Distribution

  • 00627843933236 ()
P-142

  • Gait analysis system
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
No Description
Ad-Tech Medical Instrument Corporation
0
In Commercial Distribution

  • 00841823109613 ()
BF12R-SP61X-0C3

  • Depth electrode
Device is a stool collection kit for at-home use.
Geneoscopy, Inc.
0
In Commercial Distribution

  • 00198715728941 ()


  • Faecal specimen collection kit IVD, home-use
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
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
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
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
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
YTTRIA STABILIZED ZIRCONIA, 1400 MPa BEND STRENGTH, 41% LIGHT TRANSMITTANCE
HEANY INDUSTRIES, INC.
0
In Commercial Distribution

  • 00817724020623 ()

  • Height: 30 Millimeter
  • Outer Diameter: 98 Millimeter
MDDK 3702HT30 T

  • Dental appliance fabrication material, ceramic
YTTRIA STABILIZED ZIRCONIA, 1400 MPa BEND STRENGTH, 41% LIGHT TRANSMITTANCE
HEANY INDUSTRIES, INC.
0
In Commercial Distribution

  • 00817724020616 ()

  • Height: 25 Millimeter
  • Outer Diameter: 98 Millimeter
MDDK 3702HT25 T

  • Dental appliance fabrication material, ceramic
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
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
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
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
Epicel (cultured epidermal autografts) is an aseptically processed wound dressing composed of the patient’s own (autologous) keratinocytes grown ex vivo in the presence of proliferation-arrested, murine (mouse) fibroblasts. Epicel consists of sheets of proliferative, autologous keratinocytes, ranging from 2 to 8 cell layers thick and is referred to as a cultured epidermal autograft. Each graft of Epicel is attached to petrolatum gauze backing with titanium surgical clips and measures approximately 50 cm2 in area. Epicel is authorized by Federal law for use in adult and pediatric patients who have deep dermal or full-thickness burns comprising a total body surface area greater than or equal to 30%. Epicel may be used in conjunction with split-thickness autografts, or alone in patients for whom split-thickness autografts may not be an option due to the severity and extent of their burns.
VERICEL CORPORATION
0
In Commercial Distribution

  • W41020AU201P0001 ()

  • Area/Surface Area: 50 Square centimeter


  • Cultured skin autograft/xenograft
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