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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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Invisalign Express 5 - 00816063020059

Aligner
Align Technology, Inc.
8518
In Commercial Distribution

  • 00816063020059 ()


  • Orthodontic progressive aligner

5/16 WYE - 00814005024974

5/16 WYE
Quality Aspirators, Inc.
5/16 WYE
In Commercial Distribution

  • 00814005024974 ()
313-10007

  • Dental suction system cannula, reusable

Pattern PIP 5 - 07640181161515

No Description
Keri Medical SA
211-A20005
In Commercial Distribution

  • 07640181161515 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable

Cytokeratin 5 RMab - B502BSB66020

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 RMab - B502BSB66010

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 RMab - B502BSB66000

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

EdgeTip™ #5 - 00818365020188

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

EdgeSurgicalTip™ #5 - 00818365020133

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 - B800LEAD5WBFLGC0

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 - B800LEAD5WBFCH0

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
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