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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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Drill Guide
NOVASTEP
XDG01001
In Commercial Distribution

  • 03700879500485 ()
XDG01001

  • General internal orthopaedic fixation system implantation kit
EQUIPMENT RAIL 10"
SKYTRON LLC
H8-200-02
In Commercial Distribution

  • 10841736114893 ()


  • General utility supply system, ceiling-mounted
No Description
TEKNIMED
C10A
In Commercial Distribution

  • 03760177046528 ()
C10A

  • Vertebral bone filler, non-bioabsorbable
No Description
TEKNIMED
C10A
Not in Commercial Distribution

  • 03760177041677 ()
C10A

  • Vertebral bone filler, non-bioabsorbable
The PREMIO 10 – Moxa is a medical device for heat therapy. It consists of the following: • A handpiece with a Power Supply (110-240V~ /50-60Hz) • A tip concentrator • An user manual • A cover of arrangement The PREMIO 10 - MOXA is a non-invasive infrared lamp intended to provide topical heating. The PREMIO 10 - MOXA is indicated for temporary relief of minor muscle and joint pain, arthritis and muscle spasm, relieving stiffness, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation where heat is indicated.
SEDATELEC
PREMIO 10
Not in Commercial Distribution

  • 03760262493107 ()
111237

  • Musculoskeletal infrared phototherapy unit, non-wearable
Urine Reagent Strips (URS) for Urinalysis are firm plastic strips to which several different reagent areas are affixed
Immunostics Company, Inc
IDU-10
In Commercial Distribution

  • 20722355002204 ()
  • 10722355002221 ()
  • 80722355002220 ()


  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical
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-10P
In Commercial Distribution

  • 00816125023400 ()
OB-10P

  • Bone matrix implant, synthetic, non-antimicrobial
Aligner
Align Technology, Inc.
8512
In Commercial Distribution

  • 00816063020042 ()


  • Orthodontic progressive aligner
Soprano®10 Enamel EO 100g
Cendres+Métaux SA
08057783
In Commercial Distribution

  • 07640173096559 ()
08057783

  • Dental appliance fabrication material, ceramic
Soprano®10 Enamel EO 40g
Cendres+Métaux SA
08057782
In Commercial Distribution

  • 07640173096542 ()
08057782

  • Dental appliance fabrication material, ceramic
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