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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dentaform® Band, Tooth 26, Size 35
DENTAURUM GmbH & Co.KG
883-035-00
In Commercial Distribution

  • J011883035000 ()
  • J011883035001 ()


  • Orthodontic metal band
dentaform® Snap Band, Tooth 26, Size 35
DENTAURUM GmbH & Co.KG
879-035-00
In Commercial Distribution

  • J011879035000 ()
  • J011879035001 ()


  • Orthodontic metal band
Reveal G3 Rapid HIV-1 Antibody Test is a single use, qualitative immunoassay to detect antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) in human serum or plasma. The Reveal G3 Rapid HIV-1 Antibody Test is intended for use as a point-of-care test to aid in diagnosis of infection with HIV-1. This test is suitable for use in multi-test algorithms designed for statistical validation of rapid HIV test results. When multiple rapid tests are available, this test should be used in appropriate multi-test algorithms.
MedMira Laboratories Inc
815311007569
Not in Commercial Distribution

  • 10628451188022 ()
815311007569

  • HIV1 antibody IVD, kit, rapid ICT, clinical
The package contains replacement component for use only with Reveal G3 Rapid HIV-1 Antibody Test. Components are lot-specific.
MedMira Laboratories Inc
1009785RCP-G3
Not in Commercial Distribution

  • 00628451188032 ()
1009785RCP-G3

  • HIV1 antibody IVD, kit, rapid ICT, clinical
Reveal G3 Rapid HIV-1 Antibody Test is a single use, qualitative immunoassay to detect antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) in human serum or plasma. The Reveal G3 Rapid HIV-1 Antibody Test is intended for use as a point-of-care test to aid in diagnosis of infection with HIV-1. This test is suitable for use in multi-test algorithms designed for statistical validation of rapid HIV test results. When multiple rapid tests are available, this test should be used in appropriate multi-test algorithms.
MedMira Laboratories Inc
815311000591
Not in Commercial Distribution

  • 00628451188018 ()
815311000591

  • HIV1 antibody IVD, kit, rapid ICT, clinical
dentaform® Band, tooth 26, size 35/Roth 22
DENTAURUM GmbH & Co.KG
883-335-22
In Commercial Distribution

  • J011883335220 ()


  • Orthodontic metal band
dentaform® Band, tooth 26, size 35/Roth 18
DENTAURUM GmbH & Co.KG
883-335-18
In Commercial Distribution

  • J011883335180 ()


  • Orthodontic metal band
dentaform® Band, Tooth 26, Size 35/Roth 22
DENTAURUM GmbH & Co.KG
883-035-22
Not in Commercial Distribution

  • J011883035220 ()


  • Orthodontic metal band
dentaform® Band, Tooth 26, Size 35/Roth 18
DENTAURUM GmbH & Co.KG
883-035-18
Not in Commercial Distribution

  • J011883035180 ()


  • Orthodontic metal band
Standard Band, Tooth 45/35, Size 26/Roth 22
DENTAURUM GmbH & Co.KG
862-126-22
In Commercial Distribution

  • J011862126220 ()


  • Orthodontic metal band
Standard Band, Tooth 45/35, Size 26/Roth 18
DENTAURUM GmbH & Co.KG
862-126-18
In Commercial Distribution

  • J011862126180 ()


  • Orthodontic metal band
dentaform® Snap Band, tooth 26,size 35/Roth 22
DENTAURUM GmbH & Co.KG
879-335-22
In Commercial Distribution

  • J011879335220 ()


  • Orthodontic metal band
dentaform® Snap Band, tooth 26,size 35/Roth 18
DENTAURUM GmbH & Co.KG
879-335-18
In Commercial Distribution

  • J011879335180 ()


  • Orthodontic metal band
dentaform® Snap Band, Tooth 26, Size 35/Roth 22
DENTAURUM GmbH & Co.KG
879-035-22
Not in Commercial Distribution

  • J011879035220 ()


  • Orthodontic metal band
dentaform® Snap Band, Tooth 26, Size 35/Roth 18
DENTAURUM GmbH & Co.KG
879-035-18
Not in Commercial Distribution

  • J011879035180 ()


  • Orthodontic metal band
SAFR Casting Liner Kit 6M Size 26, 28, 32, 35
Alps South, LLC
CSAFR-6MM
In Commercial Distribution

  • 00713980014409 ()


  • External limb prosthesis socket liner
SAFR Casting Liner Kit 3M Size 26, 28, 32, 35
Alps South, LLC
CSAFR-3MM
In Commercial Distribution

  • 00713980014393 ()


  • External limb prosthesis socket liner
Titanium ALIF Spacer, 35 x 26 x 20mm, 6 deg
CURITEVA, INC.
C264-352620-6
In Commercial Distribution

  • B648C26435262060 ()

  • Depth: 26 Millimeter
  • Angle: 6 degree
  • Width: 35 Millimeter
  • Height: 20 Millimeter


  • Metallic spinal interbody fusion cage
Titanium ALIF Spacer, 35 x 26 x 20mm, 12 deg
CURITEVA, INC.
C264-352620-12
In Commercial Distribution

  • B648C264352620120 ()

  • Depth: 26 Millimeter
  • Angle: 12 degree
  • Width: 35 Millimeter
  • Height: 20 Millimeter


  • Metallic spinal interbody fusion cage
Titanium ALIF Spacer, 35 x 26 x 18mm, 6 deg
CURITEVA, INC.
C264-352618-6
In Commercial Distribution

  • B648C26435261860 ()

  • Depth: 26 Millimeter
  • Angle: 6 degree
  • Width: 35 Millimeter
  • Height: 18 Millimeter


  • Metallic spinal interbody fusion cage
Titanium ALIF Spacer, 35 x 26 x 18mm, 12 deg
CURITEVA, INC.
C264-352618-12
In Commercial Distribution

  • B648C264352618120 ()

  • Depth: 26 Millimeter
  • Angle: 12 degree
  • Width: 35 Millimeter
  • Height: 18 Millimeter


  • Metallic spinal interbody fusion cage
Titanium ALIF Spacer, 35 x 26 x 16mm, 6 deg
CURITEVA, INC.
C264-352616-6
In Commercial Distribution

  • B648C26435261660 ()

  • Depth: 26 Millimeter
  • Angle: 6 degree
  • Width: 35 Millimeter
  • Height: 16 Millimeter


  • Metallic spinal interbody fusion cage
Titanium ALIF Spacer, 35 x 26 x 16mm, 12 deg
CURITEVA, INC.
C264-352616-12
In Commercial Distribution

  • B648C264352616120 ()

  • Depth: 26 Millimeter
  • Angle: 12 degree
  • Width: 35 Millimeter
  • Height: 16 Millimeter


  • Metallic spinal interbody fusion cage
Titanium ALIF Spacer, 35 x 26 x 14mm, 6 deg
CURITEVA, INC.
C264-352614-6
In Commercial Distribution

  • B648C26435261460 ()

  • Depth: 26 Millimeter
  • Angle: 6 degree
  • Width: 35 Millimeter
  • Height: 14 Millimeter


  • Metallic spinal interbody fusion cage
Titanium ALIF Spacer, 35 x 26 x 14mm, 12 deg
CURITEVA, INC.
C264-352614-12
In Commercial Distribution

  • B648C264352614120 ()

  • Depth: 26 Millimeter
  • Angle: 12 degree
  • Width: 35 Millimeter
  • Height: 14 Millimeter


  • Metallic spinal interbody fusion cage
Titanium ALIF Spacer, 35 x 26 x 12mm, 6 deg
CURITEVA, INC.
C264-352612-6
In Commercial Distribution

  • B648C26435261260 ()

  • Depth: 26 Millimeter
  • Angle: 6 degree
  • Width: 35 Millimeter
  • Height: 12 Millimeter


  • Metallic spinal interbody fusion cage
Titanium ALIF Spacer, 35 x 26 x 12mm, 12 deg
CURITEVA, INC.
C264-352612-12
In Commercial Distribution

  • B648C264352612120 ()

  • Depth: 26 Millimeter
  • Angle: 12 degree
  • Width: 35 Millimeter
  • Height: 12 Millimeter


  • Metallic spinal interbody fusion cage
Titanium ALIF Spacer, 35 x 26 x 10mm, 6 deg
CURITEVA, INC.
C264-352610-6
In Commercial Distribution

  • B648C26435261060 ()

  • Depth: 26 Millimeter
  • Angle: 6 degree
  • Width: 35 Millimeter
  • Height: 10 Millimeter


  • Metallic spinal interbody fusion cage
Titanium ALIF Spacer, 35 x 26 x 10mm, 12 deg
CURITEVA, INC.
C264-352610-12
In Commercial Distribution

  • B648C264352610120 ()

  • Depth: 26 Millimeter
  • Angle: 12 degree
  • Width: 35 Millimeter
  • Height: 10 Millimeter


  • Metallic spinal interbody fusion cage
Titanium ALIF Spacer, 35 x 26 x 8mm, 6 deg
CURITEVA, INC.
C264-352608-6
In Commercial Distribution

  • B648C26435260860 ()

  • Depth: 26 Millimeter
  • Angle: 6 degree
  • Width: 35 Millimeter
  • Height: 8 Millimeter


  • Metallic spinal interbody fusion cage
Protective Paper Covers
Premium Plus International Limited
178-2
In Commercial Distribution

  • D83817822 ()
  • D83817820 ()


  • X-ray film storage envelope
Protective Paper Covers
Premium Plus International Limited
178-1
In Commercial Distribution

  • D83817812 ()
  • D83817810 ()


  • X-ray film storage envelope
Protective Paper Covers
Premium Plus International Limited
178-0
In Commercial Distribution

  • D83817802 ()
  • D83817800 ()


  • X-ray film storage envelope
Battalion Lateral Spacer, PEEK, 15°, 26 mm Wide, 20 x 35 mm
ALPHATEC SPINE, INC.
27024-1484-S
In Commercial Distribution

  • 00190376043203 ()

  • Length: 35 Millimeter
  • Height: 20 Millimeter
  • Angle: 15 degree
  • Width: 26 Millimeter


  • Metal-polymer composite spinal interbody fusion cage
Battalion Lateral Spacer, PEEK, 10°, 26 mm Wide, 20 x 35 mm
ALPHATEC SPINE, INC.
27024-1169-S
In Commercial Distribution

  • 00190376042220 ()

  • Length: 35 Millimeter
  • Height: 20 Millimeter
  • Angle: 10 degree
  • Width: 26 Millimeter


  • Metal-polymer composite spinal interbody fusion cage
Battalion Lateral Spacer, PEEK, 10°, 26 mm Wide, 18 x 35 mm
ALPHATEC SPINE, INC.
27024-1167-S
In Commercial Distribution

  • 00190376042213 ()

  • Length: 35 Millimeter
  • Angle: 10 degree
  • Width: 26 Millimeter
  • Height: 18 Millimeter


  • Metal-polymer composite spinal interbody fusion cage
Battalion Lateral Spacer, PEEK, 10°, 26 mm Wide, 16 x 35 mm
ALPHATEC SPINE, INC.
27024-1165-S
In Commercial Distribution

  • 00190376042206 ()

  • Length: 35 Millimeter
  • Angle: 10 degree
  • Height: 16 Millimeter
  • Width: 26 Millimeter


  • Metal-polymer composite spinal interbody fusion cage
Battalion Lateral Spacer, PEEK, 10°, 26 mm Wide, 14 x 35 mm
ALPHATEC SPINE, INC.
27024-1163-S
In Commercial Distribution

  • 00190376042190 ()

  • Angle: 10 degree
  • Height: 14 Millimeter
  • Length: 35 Millimeter
  • Width: 26 Millimeter


  • Metal-polymer composite spinal interbody fusion cage
Battalion Lateral Spacer, PEEK, 10°, 26 mm Wide, 12 x 35 mm
ALPHATEC SPINE, INC.
27024-1161-S
In Commercial Distribution

  • 00190376042183 ()

  • Height: 12 Millimeter
  • Length: 35 Millimeter
  • Angle: 10 degree
  • Width: 26 Millimeter


  • Metal-polymer composite spinal interbody fusion cage
Battalion Lateral Spacer, PEEK, 10°, 26 mm Wide, 10 x 35 mm
ALPHATEC SPINE, INC.
27024-1159-S
In Commercial Distribution

  • 00190376042176 ()

  • Angle: 10 degree
  • Width: 26 Millimeter
  • Height: 10 Millimeter
  • Length: 35 Millimeter


  • Metal-polymer composite spinal interbody fusion cage
Battalion Lateral Spacer, PEEK, 6°, 26 mm Wide, 8 x 35 mm
ALPHATEC SPINE, INC.
27024-1157-S
In Commercial Distribution

  • 00190376042169 ()

  • Height: 8 Millimeter
  • Angle: 6 degree
  • Width: 26 Millimeter
  • Length: 35 Millimeter


  • Metal-polymer composite spinal interbody fusion cage
Battalion Lateral Spacer, PEEK, 0°, 26 mm Wide, 20 x 35 mm
ALPHATEC SPINE, INC.
27024-0854-S
In Commercial Distribution

  • 00190376041186 ()

  • Height: 20 Millimeter
  • Width: 26 Millimeter
  • Length: 35 Millimeter


  • Metal-polymer composite spinal interbody fusion cage
Battalion Lateral Spacer, PEEK, 0°, 26 mm Wide, 18 x 35 mm
ALPHATEC SPINE, INC.
27024-0852-S
In Commercial Distribution

  • 00190376041179 ()

  • Width: 26 Millimeter
  • Height: 18 Millimeter
  • Length: 35 Millimeter


  • Metal-polymer composite spinal interbody fusion cage
Battalion Lateral Spacer, PEEK, 0°, 26 mm Wide, 16 x 35 mm
ALPHATEC SPINE, INC.
27024-0850-S
In Commercial Distribution

  • 00190376041162 ()

  • Height: 16 Millimeter
  • Width: 26 Millimeter
  • Length: 35 Millimeter


  • Metal-polymer composite spinal interbody fusion cage
Battalion Lateral Spacer, PEEK, 0°, 26 mm Wide, 14 x 35 mm
ALPHATEC SPINE, INC.
27024-0848-S
In Commercial Distribution

  • 00190376041155 ()

  • Length: 35 Millimeter
  • Height: 14 Millimeter
  • Width: 26 Millimeter


  • Metal-polymer composite spinal interbody fusion cage
Battalion Lateral Spacer, PEEK, 0°, 26 mm Wide, 12 x 35 mm
ALPHATEC SPINE, INC.
27024-0846-S
In Commercial Distribution

  • 00190376041148 ()

  • Length: 35 Millimeter
  • Width: 26 Millimeter
  • Height: 12 Millimeter


  • Metal-polymer composite spinal interbody fusion cage
Battalion Lateral Spacer, PEEK, 0°, 26 mm Wide, 10 x 35 mm
ALPHATEC SPINE, INC.
27024-0844-S
In Commercial Distribution

  • 00190376041131 ()

  • Length: 35 Millimeter
  • Width: 26 Millimeter
  • Height: 10 Millimeter


  • Metal-polymer composite spinal interbody fusion cage
Battalion Lateral Spacer, PEEK, 0°, 26 mm Wide, 8 x 35 mm
ALPHATEC SPINE, INC.
27024-0842-S
In Commercial Distribution

  • 00190376041124 ()

  • Height: 8 Millimeter
  • Width: 26 Millimeter
  • Length: 35 Millimeter


  • Metal-polymer composite spinal interbody fusion cage
Battalion Lateral Spacer, PEEK, 0°, 26 mm Wide, 6 x 35 mm
ALPHATEC SPINE, INC.
27024-0840-S
In Commercial Distribution

  • 00190376041117 ()

  • Length: 35 Millimeter
  • Width: 26 Millimeter
  • Height: 6 Millimeter


  • Metal-polymer composite spinal interbody fusion cage
Battalion Lateral Spacer, PEEK, 15°, 26 mm Wide, 18 x 35 mm
ALPHATEC SPINE, INC.
27024-1482-S
In Commercial Distribution

  • 00190376043197 ()

  • Height: 18 Millimeter
  • Angle: 15 degree
  • Length: 35 Millimeter
  • Width: 26 Millimeter


  • Metal-polymer composite spinal interbody fusion cage
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