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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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Disposable Isolation Gown, AAMI Level 2, Large by Coulmed
New York Embroidery Studio Inc.
NYES400-1
In Commercial Distribution

  • 10860008955125 ()
  • 00860008955128 ()


  • Isolation gown, single-use
Disposable Isolation Gown, AAMI Level 2, XLarge
New York Embroidery Studio Inc.
NYES100-2
In Commercial Distribution

  • 00860008955111 ()
  • 10860008955118 ()


  • Isolation gown, single-use
Disposable Isolation Gown, AAMI Level 2, Large
New York Embroidery Studio Inc.
NYES100-1
In Commercial Distribution

  • 10860008955101 ()
  • 00860008955104 ()


  • Isolation gown, single-use
No Description
FUJIFILM NEW DEVELOPMENT U.S.A., INC.
RC-4440FN
Not in Commercial Distribution

  • 00856853006047 ()


  • Endoscopic video image processing unit
Light Source
FUJIFILM NEW DEVELOPMENT U.S.A., INC.
XL-4450FN
Not in Commercial Distribution

  • 00856853006030 ()


  • Endoscopic video image processing/light source system
Video Processor
FUJIFILM NEW DEVELOPMENT U.S.A., INC.
VP-4440FN
Not in Commercial Distribution

  • 00856853006023 ()


  • Endoscopic video image processing unit
No Description
FUJIFILM NEW DEVELOPMENT U.S.A., INC.
EL-580FN
Not in Commercial Distribution

  • 00856853006016 ()


  • Rigid video laparoscope
AROMA VITAMIN C SHOWER HEAD
Korea New Tech Co., Ltd.
AS-701ST
In Commercial Distribution

  • 08809186437028 ()


  • Lumbar spine orthosis
AROMA VITAMIN C SHOWER HEAD
Korea New Tech Co., Ltd.
AS-PRESTIGE(NORMAL)
In Commercial Distribution

  • 08809186437011 ()


  • Lumbar spine orthosis
AROMA VITAMIN C SHOWER HEAD
Korea New Tech Co., Ltd.
AS-9000
In Commercial Distribution

  • 08809186436007 ()


  • Lumbar spine orthosis
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