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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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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
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
Omnipod 5 Pod
Insulet Corporation
POD-OMNI-I1-6720
In Commercial Distribution

  • 20385083000531 ()
  • 10385083000527 ()
  • 20385083000579 ()
  • 20385083000753 ()


  • Ambulatory insulin infusion pump/interstitial glucose monitoring system
Omnipod 5 Pod
Insulet Corporation
POD-BLE-H1-520
In Commercial Distribution

  • 10385083000213 ()
  • 10385083000114 ()
  • 10385083000138 ()
  • 20385083000210 ()
  • 20385083000135 ()


  • Ambulatory insulin infusion pump/interstitial glucose monitoring system
Omnipod 5 Controller (PDM) mg/dl - English with PodPals
Insulet Corporation
PDM-H001-G-XX
In Commercial Distribution

  • 10385083000022 ()
  • 30385083000019 ()
  • 30385083000095 ()
SKT-H001-G-X9

  • Ambulatory insulin infusion pump/interstitial glucose monitoring system
Aligner
Align Technology, Inc.
8518
In Commercial Distribution

  • 00816063020059 ()


  • Orthodontic progressive aligner
OsteoBoost is a bio-engineered mixture of calcium-based inorganic compounds. After it is implanted, OsteoBoost resorbs and is later replaced by natural bone. It provides a safe alternative to human or animal cadaver bone that completely eliminates the potential for disease transmission. OsteoBoost is an osteoconductive putty that is intended to be used to fill voids and gaps that are not intrinsic to the stability of the bone structure. These gaps or voids may be located in the extremities, spine, pelvis, or cranium. The putty may be shaped and pressed into the void by hand or inserted into a syringe and injected into the surgical site. The paste set in situ or ex situ provides a void filler that can augment hardware to support bone fragments during the surgical procedure. The set putty acts as a temporary support medium and is not intended to provide structural support during the healing process. The implant is radio-opaque. It is biocompatible and resorbs in the body as bone in-growth occurs.
BERKELEY ADVANCED BIOMATERIALS, LLC
OB-05P
In Commercial Distribution

  • 00816125023394 ()
OB-05P

  • Bone matrix implant, synthetic, non-antimicrobial
No Description
Roche Diagnostics GmbH
08133859190
In Commercial Distribution

  • 07613336143162 ()
08133859190

  • Collagen type I cross-linked C-telopeptide IVD, control
No Description
ACCUTRON, INC.
34016
In Commercial Distribution

  • 00813830021813 ()
34016

  • Anaesthesia workstation gas scavenger
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