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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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Field Minor Surgery Kit
Synchronis Medical, LLC
4818-32004
In Commercial Distribution

  • 00850015884023 ()
  • 00860000925334 ()
4818-32004

  • General surgical procedure kit, non-medicated, single-use
IFAK Training Kit
Synchronis Medical, LLC
4818-50000
In Commercial Distribution

  • 00850015884016 ()
  • 00860000925327 ()
4818-50000

  • First aid kit, non-medicated, single-use
Sit-to-Stand Transfer Walker, folding, adjustable or fixed height, w/ or w/out wheels
Ganm LLC
4266SW
In Commercial Distribution

  • 00860000654401 ()


  • Handgrip disability-assistive walker, non-powered, foldable
Freehand Ring platform ring is an autoclavable ring worn on the finger during dental procedures which holds two types of disposable inserts. A foam insert used to remove debris from instrument tips during instrumentation or a well insert used to hold substances that are being applied to the oral cavity.
PURA DENTAL PRODUCTS LLC
FR403
In Commercial Distribution

  • 00860000626903 ()


  • Wearable dental procedure holding ring
  • Wearable dental procedure holding ring cleaning pad
  • Wearable dental procedure holding ring well
Modern Fertility Ovulation Test 20ct
MODERN HEALTH
A
Not in Commercial Distribution

  • 00860000599627 ()


  • Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical
Plastic manual wheelchair, for bariatric users up to 425 pounds.
Turbo Wheelchair Company, Inc.
Merlexi Craft Bariatric
In Commercial Distribution

  • 00860000595414 ()


  • Push-rim manual wheelchair, bariatric
plastic manual wheelchair, tamperproof or non-tamperproof.
Turbo Wheelchair Company, Inc.
merlexi craft wheelchair
In Commercial Distribution

  • 00860000595407 ()


  • Push-rim manual wheelchair, non-bariatric
GuideBlade, non-sterile, intended for inclusion in kits
Ambitus Medical Supplies LLC
AMB 1811
Not in Commercial Distribution

  • 20860000561918 ()
  • 00860000561914 ()
AMB 1811

  • Scalpel, single-use
Sterile GuideBlade
Ambitus Medical Supplies LLC
AMB 1746
In Commercial Distribution

  • 00860000561907 ()
  • 10860000561904 ()
  • 20860000561901 ()
  • 30860000561908 ()
AMB 1746-10

  • Scalpel, single-use
No Description
Sealcath, LLC
0006560
In Commercial Distribution

  • 10860000559130 ()
  • 00860000559133 ()

  • Catheter Gauge: 30 French


  • Barium enema catheter
  • Enema tip, single-use
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