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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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Face Mask w/ Earloops
GF HEALTH PRODUCTS, INC.
3816
In Commercial Distribution

  • M36838162 ()
  • M36838161 ()
  • M36838160 ()


  • Surgical/medical face mask, single-use
Cone Face Mask
GF HEALTH PRODUCTS, INC.
3813B
In Commercial Distribution

  • M3683813B2 ()
  • M3683813B1 ()
  • M3683813B0 ()


  • Surgical/medical face mask, single-use
APRON UTILITY 42"X36"
GF HEALTH PRODUCTS, INC.
3855
In Commercial Distribution

  • M36838552 ()
  • M36838551 ()
3855

  • Hygiene apron, single-use
APRON NECK-CLASP
GF HEALTH PRODUCTS, INC.
3853
In Commercial Distribution

  • M36838532 ()
  • M36838531 ()
3853

  • Hygiene apron, single-use
Face Mask w/ Ties
GF HEALTH PRODUCTS, INC.
3814
In Commercial Distribution

  • M36838142 ()
  • M36838141 ()
  • M36838140 ()


  • Surgical/medical face mask, single-use
Seizure Bite Stick
GF HEALTH PRODUCTS, INC.
3789
In Commercial Distribution

  • M36837892 ()
  • M36837891 ()
  • M36837890 ()


  • Seizure bite block
The GATOR is intended to be used with 12F to 24F introducer sheaths to maintain a hemostatic seal around 0.035" or 0.038" guidewires.
Vascular Solutions, Inc.
8280
Not in Commercial Distribution

  • M20682800 ()
  • M20682801 ()


  • In-line backflow valve, single-use
No Description
Vascular Solutions, Inc.
8216
Not in Commercial Distribution

  • M20682160 ()
  • M20682161 ()


  • Haemostasis valve
The Guardian hemostasis valves are intended to maintain hemostasis during the use of diagnostic or interventional devices. Guardian hemostasis valves are indicated for maintaining a seal around diagnostic/interventional devices with outside diameters up to 8F (0.105" or 2.67mm) during diagnostic/interventional procedures.
Vascular Solutions, Inc.
8215
Not in Commercial Distribution

  • M20682150 ()
  • M20682151 ()


  • Haemostasis valve
The Guardian hemostasis valves are intended to maintain hemostasis during the use of diagnostic or interventional devices. Guardian hemostasis valves are indicated for maintaining a seal around diagnostic/interventional devices with outside diameters up to 8F (0.105" or 2.67mm) during diagnostic/interventional procedures. The torque device is provided as an aid for steering the guidewire within the vascular anatomy.
Vascular Solutions, Inc.
8211
Not in Commercial Distribution

  • M20682110 ()
  • M20682111 ()


  • Haemostasis valve
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