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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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Pro Advantage Pouch 2.75 X 9
NATIONAL DISTRIBUTION & CONTRACTING, INC.
P012790
In Commercial Distribution

  • M220P0127905 ()
  • M220P0127903 ()
P012790

  • Sterilization packaging, single-use
Pro Advantage CSR Wrap 24 X 24
NATIONAL DISTRIBUTION & CONTRACTING, INC.
P012424
In Commercial Distribution

  • M220P0124245 ()
  • M220P0124242 ()
P012424

  • Sterilization packaging, single-use
Pro Advantage CSR Wrap 20 X 20
NATIONAL DISTRIBUTION & CONTRACTING, INC.
P012020
In Commercial Distribution

  • M220P0120205 ()
  • M220P0120202 ()
P012020

  • Sterilization packaging, single-use
Pro Advantage CSR Wrap 15 X 15
NATIONAL DISTRIBUTION & CONTRACTING, INC.
P011515
In Commercial Distribution

  • M220P0115155 ()
  • M220P0115152 ()
P011515

  • Sterilization packaging, single-use
Pro Advantage Pouch 3.5 X 9
NATIONAL DISTRIBUTION & CONTRACTING, INC.
P013590
In Commercial Distribution

  • M220P0135905 ()
  • M220P0103903 ()
P013590

  • Sterilization packaging, single-use
Pro Advantage Glutaraldehyde 28 Gallon
NATIONAL DISTRIBUTION & CONTRACTING, INC.
N099002
In Commercial Distribution

  • M220N0990025 ()
  • M220N0990028 ()
N099002

  • Glutaraldehyde device sterilant
Pro Advantage Glutaraldehyde 14 Gallon
NATIONAL DISTRIBUTION & CONTRACTING, INC.
N099001
In Commercial Distribution

  • M220N0990015 ()
  • M220N0990018 ()
N099001

  • Glutaraldehyde device sterilant
PA CAP BOUFFANT 21 BLU 100/BX 5BX/CS
NATIONAL DISTRIBUTION & CONTRACTING, INC.
P701015
In Commercial Distribution

  • M22097010155 ()
  • M22007010153 ()
P701015

  • Surgical cap, single-use
BIB PATIENT/GERIATRIC
GF HEALTH PRODUCTS, INC.
3856
In Commercial Distribution

  • M36838562 ()
  • M36838561 ()
3856

  • Hygiene apron, single-use
APRON UTILITY 36"X27"
GF HEALTH PRODUCTS, INC.
3854
In Commercial Distribution

  • M36838542 ()
  • M36838541 ()
3854

  • Hygiene apron, single-use
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
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.
8210
Not in Commercial Distribution

  • M20682101 ()
  • M20682100 ()


  • Haemostasis valve
The VSI Torque Device is intended for use in manipulating a guidewire that is in the vasculature.
Vascular Solutions, Inc.
8181
Not in Commercial Distribution

  • M20681810 ()
  • M20681811 ()


  • Torque manipulation device
The AngioAssist Docking Station is intended to stabilize and load guidewires and catheters during percutaneous procedures.
Vascular Solutions, Inc.
8151
Not in Commercial Distribution

  • M20681511 ()
  • M20681510 ()


  • Medical device service rail
The Teirstein Edge Device Organizer is intended to stabilize and load guidewires and catheters during percutaneous procedures.
Vascular Solutions, Inc.
8150
Not in Commercial Distribution

  • M20681501 ()
  • M20681500 ()


  • Medical device service rail
No Description
Vascular Solutions, Inc.
7960
Not in Commercial Distribution

  • M20679600 ()
  • M20679601 ()

  • Length: 20 Centimeter
  • Catheter Gauge: 6 French


  • Vascular catheter introduction set, nonimplantable
The GrebSet micro-introducer kit is indicated for use in percutaneous introduction and placement of catheters and guidewires.
Vascular Solutions, Inc.
7952
Not in Commercial Distribution

  • M20679520 ()
  • M20679521 ()

  • Catheter Gauge: 5 French
  • Needle Gauge: 21 Gauge


  • Vascular catheter introduction set, nonimplantable
The GrebSet micro-introducer kit is indicated for use in percutaneous introduction and placement of catheters and guidewires.
Vascular Solutions, Inc.
7951
Not in Commercial Distribution

  • M20679511 ()
  • M20679510 ()

  • Catheter Gauge: 5 French
  • Needle Gauge: 21 Gauge


  • Vascular catheter introduction set, nonimplantable
The GrebSet micro-introducer kit is indicated for use in percutaneous introduction and placement of catheters and guidewires.
Vascular Solutions, Inc.
7950
Not in Commercial Distribution

  • M20679501 ()
  • M20679500 ()

  • Catheter Gauge: 5 French
  • Needle Gauge: 21 Gauge


  • Vascular catheter introduction set, nonimplantable
No Description
Vascular Solutions, Inc.
7941
Not in Commercial Distribution

  • M20679410 ()
  • M20679411 ()

  • Length: 45 Centimeter
  • Catheter Gauge: 5 French


  • Vascular catheter introduction set, nonimplantable
Use of the SmartNeedle device is indicated when blood flow must be detected for percutaneous vessel cannulation. The vessel must be of a caliber which would normally be punctured with a needle and/or catheter of this size or larger.
Vascular Solutions, Inc.
78130
Not in Commercial Distribution

  • M206781301 ()
  • M206781300 ()

  • Needle Gauge: 22 Gauge


  • Noninvasive vascular ultrasound system
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