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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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GORE EXCLUDER AAA Endoprosthesis with C3 Delivery - 00733132610518

No Description
W. L. Gore & Associates, Inc.
RMT231214
Not in Commercial Distribution

  • H373RMT2312143 ()
  • 00733132610518 ()

  • Length: 14 Centimeter
  • Outer Diameter: 12 Millimeter
  • Outer Diameter: 23 Millimeter


  • Abdominal aorta endovascular stent-graft

GORE EXCLUDER AAA Endoprosthesis with C3 Delivery - 00733132619092

EXCLUDER AAA ENDO TRNK IPSI 31mmX14.5mmX17cm 18Fr
W. L. Gore & Associates, Inc.
RLT311417
In Commercial Distribution

  • H373RLT3114173 ()
  • 00733132619092 ()

  • Outer Diameter: 31 Millimeter
  • Outer Diameter: 14.5 Millimeter
  • Length: 17 Centimeter
RLT311417

  • Abdominal aorta endovascular stent-graft

GORE EXCLUDER AAA Endoprosthesis with C3 Delivery - 00733132619085

EXCLUDER AAA ENDO TRNK IPSI 31mmX14.5mmX15cm 18Fr
W. L. Gore & Associates, Inc.
RLT311415
In Commercial Distribution

  • H373RLT3114153 ()
  • 00733132619085 ()

  • Length: 15 Centimeter
  • Outer Diameter: 14.5 Millimeter
  • Outer Diameter: 31 Millimeter
RLT311415

  • Abdominal aorta endovascular stent-graft

GORE EXCLUDER AAA Endoprosthesis with C3 Delivery - 00733132618491

EXCLUDER AAA ENDO TRNK IPSI 35mmX14.5mmX18cm 18Fr
W. L. Gore & Associates, Inc.
RLT351418
In Commercial Distribution

  • H373RLT35141831 ()
  • 00733132618491 ()

  • Length: 18 Centimeter
  • Outer Diameter: 14.5 Millimeter
  • Outer Diameter: 35 Millimeter
RLT351418

  • Abdominal aorta endovascular stent-graft

GORE EXCLUDER AAA Endoprosthesis with C3 Delivery - 00733132618484

EXCLUDER AAA ENDO TRNK IPSI 35mmX14.5mmX16cm 18Fr
W. L. Gore & Associates, Inc.
RLT351416
In Commercial Distribution

  • H373RLT3514163 ()
  • 00733132618484 ()

  • Outer Diameter: 35 Millimeter
  • Outer Diameter: 14.5 Millimeter
  • Length: 16 Centimeter
RLT351416

  • Abdominal aorta endovascular stent-graft

GORE EXCLUDER AAA Endoprosthesis with C3 Delivery - 00733132618477

EXCLUDER AAA ENDO TRNK IPSI 35mmX14.5mmX14cm 18Fr
W. L. Gore & Associates, Inc.
RLT351414
In Commercial Distribution

  • H373RLT3514143 ()
  • 00733132618477 ()

  • Length: 14 Centimeter
  • Outer Diameter: 14.5 Millimeter
  • Outer Diameter: 35 Millimeter
RLT351414

  • Abdominal aorta endovascular stent-graft

Reference Sensor Clip with Adhesive Patch for use with the ENVizion® ENVue® Syst - B4831RSC011

For full information, Envue System User Manual (6100-1) and IFU (6201-01) OVERVIEW OF SYSTEM The ENvizion Medical ENvue System is an electromagnetic sensing device designed to aid qualified operators in the placement of the ENvizion Enteral Feeding Tube (EFT) into the stomach or small intestine of patients requiring enteral feeding. The ENvizion ENvue System is intended as an adjunct to current placement practices for assisting clinical practitioners who place feeding tubes, prior to commencing the delivery of enteral nutrition. Although this System has been designed to exacting specifications, it is not intended to replace trained personnel in the supervision of feeding tube placements. Only clinical personnel familiar with the placement of oro/nasoenteric tubes should perform tube placements. As placement is performed, the all-in-one PC displays the relative tip position and track. The entire placement is recorded and may be replayed later. The ENvizion Enteral Feeding Tube’s position must be confirmed per institution protocol (i.e., X- ray, pH measurement, etc.). 3. CONDITIONS FOR USE 3.1. INDICATIONS FOR USE The ENvizion Medical ENvue System is designed to aid qualified operators in the placement of the ENvizion Medical Enteral Feeding Tube of 8 Fr to 12 Fr into the stomach or small intestine of adult patients requiring enteral feeding. The ENvizion Medical ENvue System is intended as an adjunct to current placement practices for assisting clinical practitioners who place feeding tubes. The ENvizion Medical Enteral Feeding Tube (EFT) has been specifically designed for use with the ENvue System and is intended for placement in the stomach or small intestine. It is intended for use in adult patients who require intermittent or continuous feeding via the oro/nasoenteric route. The EFT is intended only to be used with a feeding pump and is not compatible with gravity-based feeding bags.
ENVIZION MEDICAL LTD
1RSC01
In Commercial Distribution

  • B4831RSC010 ()
  • B4831RSC011 ()
ENV-30000

  • Nasogastric feeding tube

SNAP™ - M595S4820

170gm Characterized Pink SNAP™ Resin
PARKELL, INC.
S482
Not in Commercial Distribution

  • M595S4820 ()
S482

  • Temporary dental crown/bridge resin

SNAP™ - M595S4810

Characterized Pink SNAP™ Resin 40gm
PARKELL, INC.
S481
Not in Commercial Distribution

  • M595S4810 ()
S481

  • Temporary dental crown/bridge resin

SNAP™ - M595S4800

170gm SNAP™ Resin Shade 81
PARKELL, INC.
S480
Not in Commercial Distribution

  • M595S4800 ()
S480

  • Temporary dental crown/bridge resin
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