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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Brigade Lateral, 13x38x28mm 25°
Nuvasive, Inc.
6985338
In Commercial Distribution

  • 00887517967756 ()


  • Metallic spinal interbody fusion cage
Brigade Lateral, 13x34x24mm 25°
Nuvasive, Inc.
6985334
In Commercial Distribution

  • 00887517967749 ()


  • Metallic spinal interbody fusion cage
Brigade Lateral, 12x38x28mm 25°
Nuvasive, Inc.
6985238
In Commercial Distribution

  • 00887517967732 ()


  • Metallic spinal interbody fusion cage
Brigade Lateral, 12x34x24mm 25°
Nuvasive, Inc.
6985234
In Commercial Distribution

  • 00887517967725 ()


  • Metallic spinal interbody fusion cage
Brigade Lateral, 11x38x28mm 25°
Nuvasive, Inc.
6985138
In Commercial Distribution

  • 00887517967718 ()


  • Metallic spinal interbody fusion cage
Brigade Lateral, 11x34x24mm 25°
Nuvasive, Inc.
6985134
In Commercial Distribution

  • 00887517967701 ()


  • Metallic spinal interbody fusion cage
Brigade Lateral, 10x38x28mm 25°
Nuvasive, Inc.
6985038
In Commercial Distribution

  • 00887517967695 ()


  • Metallic spinal interbody fusion cage
Brigade Lateral, 10x34x24mm 25°
Nuvasive, Inc.
6985034
In Commercial Distribution

  • 00887517967688 ()


  • Metallic spinal interbody fusion cage
Brigade Lateral, 9x38x28mm 25°
Nuvasive, Inc.
6984938
In Commercial Distribution

  • 00887517967671 ()


  • Metallic spinal interbody fusion cage
Brigade Lateral, 9x34x24mm 25°
Nuvasive, Inc.
6984934
In Commercial Distribution

  • 00887517967664 ()


  • Metallic spinal interbody fusion cage
Brigade Lateral, 8x38x28mm 25°
Nuvasive, Inc.
6984838
In Commercial Distribution

  • 00887517967657 ()


  • Metallic spinal interbody fusion cage
Brigade Lateral, 8x34x24mm 25°
Nuvasive, Inc.
6984834
In Commercial Distribution

  • 00887517967640 ()


  • Metallic spinal interbody fusion cage
Brigade Lateral, 7x38x28mm 25°
Nuvasive, Inc.
6984738
In Commercial Distribution

  • 00887517967633 ()


  • Metallic spinal interbody fusion cage
Brigade Lateral, 7x34x24mm 25°
Nuvasive, Inc.
6984734
In Commercial Distribution

  • 00887517967626 ()


  • Metallic spinal interbody fusion cage
Brigade Lateral, 6x38x28mm 25°
Nuvasive, Inc.
6984638
In Commercial Distribution

  • 00887517967619 ()


  • Metallic spinal interbody fusion cage
Brigade Lateral, 6x34x24mm 25°
Nuvasive, Inc.
6984634
In Commercial Distribution

  • 00887517967602 ()


  • Metallic spinal interbody fusion cage
Brigade Lateral, 14x34x32mm 25°
Nuvasive, Inc.
6972170
In Commercial Distribution

  • 00887517967107 ()


  • Metallic spinal interbody fusion cage
Brigade Lateral, 13x34x32mm 25°
Nuvasive, Inc.
6972169
In Commercial Distribution

  • 00887517967091 ()


  • Metallic spinal interbody fusion cage
Brigade Lateral, 12x34x32mm 25°
Nuvasive, Inc.
6972168
In Commercial Distribution

  • 00887517967084 ()


  • Metallic spinal interbody fusion cage
Brigade Lateral, 11x34x32mm 25°
Nuvasive, Inc.
6972167
In Commercial Distribution

  • 00887517967077 ()


  • Metallic spinal interbody fusion cage
Brigade Lateral, 10x34x32mm 25°
Nuvasive, Inc.
6972166
In Commercial Distribution

  • 00887517967060 ()


  • Metallic spinal interbody fusion cage
Brigade Lateral, 9x34x32mm 25°
Nuvasive, Inc.
6972165
In Commercial Distribution

  • 00887517967053 ()


  • Metallic spinal interbody fusion cage
Brigade Lateral, 8x34x32mm 25°
Nuvasive, Inc.
6972164
In Commercial Distribution

  • 00887517967046 ()


  • Metallic spinal interbody fusion cage
Brigade Lateral, 7x34x32mm 25°
Nuvasive, Inc.
6972163
In Commercial Distribution

  • 00887517967039 ()


  • Metallic spinal interbody fusion cage
Brigade Lateral, 6x34x32mm 25°
Nuvasive, Inc.
6972162
In Commercial Distribution

  • 00887517967022 ()


  • Metallic spinal interbody fusion cage
SA ALIF, 30Dx40Wx20H 25°
NEXXT SPINE, LLC
61-3040-20-25-SP
In Commercial Distribution

  • 00889929042489 ()

  • Width: 40 Millimeter
  • Depth: 30 Millimeter
  • Angle: 25 degree
  • Height: 20 Millimeter


  • Metallic spinal interbody fusion cage
SA ALIF, 30Dx40Wx18H 25°
NEXXT SPINE, LLC
61-3040-18-25-SP
In Commercial Distribution

  • 00889929042472 ()

  • Width: 40 Millimeter
  • Depth: 30 Millimeter
  • Angle: 25 degree
  • Height: 18 Millimeter


  • Metallic spinal interbody fusion cage
SA ALIF, 30Dx40Wx16H 25°
NEXXT SPINE, LLC
61-3040-16-25-SP
In Commercial Distribution

  • 00889929042465 ()

  • Width: 40 Millimeter
  • Depth: 30 Millimeter
  • Angle: 25 degree
  • Height: 16 Millimeter


  • Metallic spinal interbody fusion cage
SA ALIF, 27Dx36Wx20H 25°
NEXXT SPINE, LLC
61-2736-20-25-SP
In Commercial Distribution

  • 00889929042458 ()

  • Width: 36 Millimeter
  • Depth: 27 Millimeter
  • Angle: 25 degree
  • Height: 20 Millimeter


  • Metallic spinal interbody fusion cage
SA ALIF, 27Dx36Wx18H 25°
NEXXT SPINE, LLC
61-2736-18-25-SP
In Commercial Distribution

  • 00889929042441 ()

  • Width: 36 Millimeter
  • Depth: 27 Millimeter
  • Angle: 25 degree
  • Height: 18 Millimeter


  • Metallic spinal interbody fusion cage
SA ALIF, 27Dx36Wx16H 25°
NEXXT SPINE, LLC
61-2736-16-25-SP
In Commercial Distribution

  • 00889929042434 ()

  • Width: 36 Millimeter
  • Depth: 27 Millimeter
  • Angle: 25 degree
  • Height: 16 Millimeter


  • Metallic spinal interbody fusion cage
SA ALIF, 24Dx32Wx20H 25°
NEXXT SPINE, LLC
61-2432-20-25-SP
In Commercial Distribution

  • 00889929042427 ()

  • Width: 32 Millimeter
  • Depth: 24 Millimeter
  • Angle: 25 degree
  • Height: 20 Millimeter


  • Metallic spinal interbody fusion cage
SA ALIF, 24Dx32Wx18H 25°
NEXXT SPINE, LLC
61-2432-18-25-SP
In Commercial Distribution

  • 00889929042410 ()

  • Width: 32 Millimeter
  • Depth: 24 Millimeter
  • Angle: 25 degree
  • Height: 18 Millimeter


  • Metallic spinal interbody fusion cage
SA ALIF, 24Dx32Wx16H 25°
NEXXT SPINE, LLC
61-2432-16-25-SP
In Commercial Distribution

  • 00889929042403 ()

  • Width: 32 Millimeter
  • Depth: 24 Millimeter
  • Angle: 25 degree
  • Height: 16 Millimeter


  • Metallic spinal interbody fusion cage
SA ALIF, 30Dx40Wx14H 25°
NEXXT SPINE, LLC
61-3040-14-25-SP
In Commercial Distribution

  • 00889929040157 ()

  • Width: 40 Millimeter
  • Depth: 30 Millimeter
  • Angle: 25 degree
  • Height: 14 Millimeter


  • Metallic spinal interbody fusion cage
SA ALIF, 27Dx36Wx14H 25°
NEXXT SPINE, LLC
61-2736-14-25-SP
In Commercial Distribution

  • 00889929040119 ()

  • Width: 36 Millimeter
  • Depth: 27 Millimeter
  • Angle: 25 degree
  • Height: 14 Millimeter


  • Metallic spinal interbody fusion cage
SA ALIF, 24Dx32Wx14H 25°
NEXXT SPINE, LLC
61-2432-14-25-SP
In Commercial Distribution

  • 00889929040072 ()

  • Width: 32 Millimeter
  • Depth: 24 Millimeter
  • Angle: 25 degree
  • Height: 14 Millimeter


  • Metallic spinal interbody fusion cage
H. 25 mm, refill
BIOLOREN SRL
IF25
In Commercial Distribution

  • 08056099230059 ()

  • Height: 25 Millimeter


  • Dental reinforcing fibre
No Description
Biomet Orthopedics, LLC
P382
In Commercial Distribution

  • 00887868117862 ()
P382

  • Orthopaedic bone staple, non-adjustable
c-Kit pharmDx
AGILENT TECHNOLOGIES, INC.
K1906
Not in Commercial Distribution

  • 05700571104040 ()

  • 25 Tests


  • CD117 (c-kit) cell marker IVD, kit, enzyme immunohistochemistry
Tubifast Vest 2 - 5 yrs x 6
Mölnlycke Health Care AB
992008
In Commercial Distribution

  • 05055158000810 ()
  • 05055158000766 ()
  • 07332551959036 ()

  • 2-5 years


  • Tubular support bandage, non-latex, reusable
Tubifast Leggings 2 - 5 yrs x 6
Mölnlycke Health Care AB
992013
In Commercial Distribution

  • 05055158000865 ()
  • 05055158000711 ()
  • 07332551959180 ()

  • 2-5 years


  • Tubular support bandage, non-latex, reusable
The ImmunoDOT Autoimmunity Screening Panel 1 is an enzyme immunoassay (EIA) test for screening and detection of autoantibodies against various specific nuclear antigens in serum and heparinized whole blood and used as an aid in the diagnosis of autoimmune disorders. This product is intended for use in physician offices and clinical laboratories.
Genbio
800-5125
In Commercial Distribution

  • 00613745051253 ()

  • 25 tests
5125

  • Multiple antinuclear antibody (ANA) screening IVD, kit, multiplex
The ImmunoDOT Thyroid Autoimmunity Panel is an enzyme immunoassay (EIA) test for screening and detection of autoantibodies against human thyroglobulin and human thyroid peroxidase (microsome) in serum and heparinized whole blood and is used as an aid in the diagnosis of thyroid disorders. This product is intended for use in physician offices and clinical laboratories.
Genbio
800-5825
In Commercial Distribution

  • 00613745058252 ()

  • 25 tests
5825

  • Multiple thyroid antibody IVD, kit, enzyme immunoassay (EIA)
The ImmunoDOT Autoimmunity Screening Panel 4 is an enzyme immunoassay (EIA) test for screening and detection of autoantibodies against various specific nuclear antigens in serum and heparinized whole blood and used as an aid in the diagnosis of autoimmune disorders. This product is intended for use in physician offices and clinical laboratories.
Genbio
800-5425
In Commercial Distribution

  • 00613745054254 ()

  • 25 tests
5425

  • Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, kit, multiplex
The ImmunoDOT Borrelia (Lyme) test is an enzyme immunoassay (EIA) dot-blot test for the qualitative detection of Borrelia antibodies. Both species specific (anti-P39) and related Borrelia burgdorferi antibodies (IgG, IgM, and IgA) are detected in serum as an aid in the diagnosis of Lyme disease.
Genbio
800-5025
In Commercial Distribution

  • 00613745050256 ()

  • 25 tests
5025

  • Borrelia burgdorferi total antibody IVD, kit, immunoblot
The GenBio Salmonella typhi ImmunoDOT test is an enzyme immunoassay for the detection of antibodies to Salmonella (typhoid fever) for the serological confirmation of infections in serum, plasma or heparinized whole blood. This test is intended to be performed by trained laboratory personnel only.
Genbio
800-4040
In Commercial Distribution

  • 00613745000053 ()

  • 25 tests
4040

  • Salmonella typhi total antibody IVD, kit, immunoblot
The GenBio IgM ImmunoDOT Leptospira test is a qualitative enzyme immunoassay that specifically detects IgM antibodies to Leptospira biflexa (serovar patoc 1). This test is presumptive for the laboratory diagnosis of leptospirosis. The IgM ImmunoDOT Test may be used to evaluate a single specimen or paired specimens to detect seroconversion. The test is intended for use in serum, plasma, heparinized whole blood or finger stick capillary blood.
Genbio
800-4030
In Commercial Distribution

  • 00613745000046 ()

  • 25 tests
4030

  • Multiple Leptospira species immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
Perform Full Wedge
TORNIER, INC.
9027305
In Commercial Distribution

  • 00846832096251 ()

  • Size: 25
9027305

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Perform Half Wedge
TORNIER, INC.
9027303
In Commercial Distribution

  • 00846832096237 ()

  • Size: 25
9027303

  • Orthopaedic prosthesis implantation positioning instrument, reusable
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