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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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Aligner
Align Technology, Inc.
8518
In Commercial Distribution

  • 00816063020059 ()


  • Orthodontic progressive aligner
5/16 WYE
Quality Aspirators, Inc.
5/16 WYE
In Commercial Distribution

  • 00814005024974 ()
313-10007

  • Dental suction system cannula, reusable
No Description
Keri Medical SA
211-A20005
In Commercial Distribution

  • 07640181161515 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Cytokeratin 5 is a rabbit monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Concentrate, 1 ml
In Commercial Distribution

  • B502BSB66020 ()
BSB 6602

  • Cytokeratin IVD, antibody
Cytokeratin 5 is a rabbit monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Concentrate, 0.5 ml
In Commercial Distribution

  • B502BSB66010 ()
BSB 6601

  • Cytokeratin IVD, antibody
Cytokeratin 5 is a rabbit monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Concentrate, 0.1 ml
In Commercial Distribution

  • B502BSB66000 ()
BSB 6600

  • Cytokeratin IVD, antibody
Long retreatment tip for the retreatment of very hard materials in the middle third
EDGE ENDO LLC
ET40D5
In Commercial Distribution

  • 00818365020188 ()


  • Ultrasonic dental scaling/debridement system handpiece tip, endodontic
Diamond-coated right-angled retro tip for preparing pre-molar and molar canals
EDGE ENDO LLC
P15RD
In Commercial Distribution

  • 00818365020133 ()


  • Ultrasonic dental scaling/debridement system handpiece tip, endodontic
LEAD LEVEL 5
UTAK LABORATORIES, INC.
LEAD 5 WB F LGC
In Commercial Distribution

  • B800LEAD5WBFLGC0 ()

  • Total Volume: 5 Milliliter
LEAD 5 WB F LGC

  • Multiple-type clinical chemistry analyte profile IVD, control
LEAD LEVEL 5
UTAK LABORATORIES, INC.
LEAD 5 WB F CH
In Commercial Distribution

  • B800LEAD5WBFCH5 ()
  • B800LEAD5WBFCH0 ()

  • Total Volume: 0.5 Milliliter
LEAD 5 WB F CH

  • Multiple-type clinical chemistry analyte profile IVD, control
DAU CALIBRATOR 5
UTAK LABORATORIES, INC.
DAU CAL 5 F IUH
In Commercial Distribution

  • B800DAUCAL5FIUH5 ()
  • B800DAUCAL5FIUH0 ()

  • Total Volume: 0.5 Milliliter
DAU CAL 5 F IUH

  • Multiple-type clinical chemistry analyte profile IVD, control
THC LEVEL 5
UTAK LABORATORIES, INC.
THC 5 U F WDH
In Commercial Distribution

  • B800THC5UFWDH5 ()
  • B800THC5UFWDH0 ()

  • Total Volume: 10 Milliliter
THC 5 U F WDH

  • Multiple-type clinical chemistry analyte profile IVD, control
IMMUNOSUPPRESSANTS LEVEL 5
UTAK LABORATORIES, INC.
IMMUN 5 WB F UNC
In Commercial Distribution

  • B800IMMUN5WBFUNC5 ()
  • B800IMMUN5WBFUNC0 ()

  • Total Volume: 2.5 Milliliter
IMMUN 5 WB F UNC

  • Multiple-type clinical chemistry analyte profile IVD, control
IMMUNOSUPPRESSANTS LEVEL 5
UTAK LABORATORIES, INC.
IMMU 5 WB WDL
In Commercial Distribution

  • B800IMMU5WBWDL5 ()
  • B800IMMU5WBWDL0 ()

  • Total Volume: 3 Milliliter
IMMU 5 WB WDL

  • Multiple-type clinical chemistry analyte profile IVD, control
POLYAXIAL SCREW
Stryker Corporation
48145570
In Commercial Distribution

  • 07613154122523 ()

  • Diameter: 5.5 Millimeter
  • Length: 70.0 Millimeter
48145570

  • Spinal bone screw, non-bioabsorbable
POLYAXIAL SCREW
Stryker Corporation
48145560
In Commercial Distribution

  • 07613154122516 ()

  • Diameter: 5.5 Millimeter
  • Length: 60.0 Millimeter
48145560

  • Spinal bone screw, non-bioabsorbable
POLYAXIAL SCREW
Stryker Corporation
48145555
In Commercial Distribution

  • 07613154122509 ()

  • Length: 55.0 Millimeter
  • Diameter: 5.5 Millimeter
48145555

  • Spinal bone screw, non-bioabsorbable
POLYAXIAL SCREW
Stryker Corporation
48145070
In Commercial Distribution

  • 07613154122431 ()

  • Diameter: 5.0 Millimeter
  • Length: 70.0 Millimeter
48145070

  • Spinal bone screw, non-bioabsorbable
POLYAXIAL SCREW
Stryker Corporation
48145060
In Commercial Distribution

  • 07613154122424 ()

  • Diameter: 5.0 Millimeter
  • Length: 60.0 Millimeter
48145060

  • Spinal bone screw, non-bioabsorbable
POLYAXIAL SCREW
Stryker Corporation
48145050
In Commercial Distribution

  • 07613154122417 ()

  • Length: 50.0 Millimeter
  • Diameter: 5.0 Millimeter
48145050

  • Spinal bone screw, non-bioabsorbable
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