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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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Glide Disposable Tip one pc.
ALMA LASERS LTD.
1
Not in Commercial Distribution

  • 17290110122192 ()
AARF15112101

  • Radio-frequency skin contouring system
One Thing Silver (Polarized) Spectacle
Kenmark Optical, Inc.
OTHGSI52
In Commercial Distribution

  • 00715317176217 ()


  • Tinted non-prescription spectacles
One Thing Gold (Polarized) Spectacle
Kenmark Optical, Inc.
OTHGYG52
In Commercial Distribution

  • 00715317176170 ()


  • Tinted non-prescription spectacles
kit only has one meter
BIONIME CORPORATION
GM291
In Commercial Distribution

  • 00883489002525 ()
  • 00883489002518 ()
  • 10883489002522 ()
  • 20883489002529 ()


  • Glucose monitoring system IVD, home-use
Reline One Instrument Set - Alpha
Nuvasive, Inc.
ALPRELONEIN
In Commercial Distribution

  • 00195377098443 ()


  • Device sterilization/disinfection container, reusable
One Touch Ultra Control Solution
LifeScan Europe GmbH
010-458
In Commercial Distribution

  • 20353885458027 ()
  • 00353885458023 ()
  • 53885-458-02 ()
  • 80353885458029 ()
010-458

  • Glucose monitoring system IVD, point-of-care
One Touch Lancing Device Warr
LifeScan Europe GmbH
021-242
In Commercial Distribution

  • 00353885012126 ()
  • 20353885012120 ()


  • Manual blood lancing device, reusable
One Touch Ultra Control Solution
LifeScan Europe GmbH
021-416
In Commercial Distribution

  • 20353885006235 ()
  • 00353885006231 ()
  • 53885-937-01 ()
021-416

  • Glucose monitoring system IVD, point-of-care
HEATH Chalazion Curette, one sharp and one blunt edge, size 3, 3mm, 4"
BR Surgical, LLC
BR42-10413
In Commercial Distribution

  • 00840183513436 ()
BR42-10413

  • Ophthalmic curette, reusable
8.3 inch Fomon Rasp, Double Ended, One Convex, One Flat, Tip Width 7.5mm
Surgical Direct, Inc.
SD921377100
In Commercial Distribution

  • B382SD9213771000 ()
SD921377100

  • Orthopaedic osteotome
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