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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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19ga, 7cm, 1-part needle
PROCEDURE PRODUCTS, INC.
229-357
In Commercial Distribution

  • B1602293572 ()
  • B1602293571 ()


  • Vascular catheter introduction needle
NEEDLE, BSDN PLATE 1 PART 9 CM 18g
PROCEDURE PRODUCTS, INC.
21-1835
In Commercial Distribution

  • B1602118352 ()
  • B1602118351 ()


  • Vascular catheter introduction needle
DESCRIPTION The Waters WCM is primarily made of polycarbonate plastic. The pre-sterilized cassette contains a complete circulatory system (refer to diagram), designed for use on the Waters WAVES control unit. HOW SUPPLIED: The Waters WCM cassette is wrapped in a sterile wrap, sealed in a polyethylene bag, and is provided STERILE (ethylene oxide) fluid pathway. The Waters WCM cassette is intended for single-use only. CONTENTS: One (1) STERILE Waters WCM disposable cassette. One (1) STERILE Drape.Five (5) STERILE Specimen Tubes
WATERS MEDICAL SYSTEMS, LLC
WCM Kit
In Commercial Distribution

  • 3930005014 ()
  • B154W39300050123 ()
3930005.014

  • Kidney donor-organ preservation/transport perfusion set
Sterile WCM drape. For use with WAVES/WCM perfusion control unit.
WATERS MEDICAL SYSTEMS, LLC
DRAPE STERILE PACK - 1drape/bag (included in WCM cassettes kit)
In Commercial Distribution

  • 3910140001 ()
  • B154W39300050020 ()
3910140.001

  • Kidney donor-organ preservation/transport perfusion set
Arterial Perfusion Occlusion Clamp - 2ct/pkg
WATERS MEDICAL SYSTEMS, LLC
Arterial Perfusion Occlusion Clamp
In Commercial Distribution

  • B154R3920140024C00 ()
  • 3920140024 ()
3920140.024

  • Kidney donor-organ preservation/transport perfusion set
The cassette is a self-contained circulation system consisting of an organ chamber, a venous and arterial reservoir, a bubble trap, a membrane oxygenator, a heat exchanger and pulsatile pump head. The system can provide circulation of one liter of PPS (machine perfusate) to one or two kidneys. The kidneys are attached to the arterial ports either in single fashion, or can be placed enbloc.
WATERS MEDICAL SYSTEMS, LLC
DCM Kidney Cassette
In Commercial Distribution

  • B154R00126910000 ()
  • 0008190000 ()
0012691.000

  • Kidney donor-organ preservation/transport perfusion set
272 micrometer ScopeSafe™ Laser Fiber with Soft Tip
OPTICAL INTEGRITY INC
11521
In Commercial Distribution

  • B145115211 ()
  • B145115210 ()

  • Outer Diameter: 272 Micrometer


  • General/multiple surgical laser system beam guide, reusable
550 micrometer laser Fiber With SMA 905 Connector and Resistive Interlocking Sleeve
OPTICAL INTEGRITY INC
11414
In Commercial Distribution

  • B145114141 ()
  • B145114140 ()

  • Outer Diameter: 550 Micrometer
  • fiber core diameter


  • General/multiple surgical laser system beam guide, reusable
272 micrometer laser Fiber With SMA 905 Connector and Resistive Interlocking Sleeve
OPTICAL INTEGRITY INC
11410
In Commercial Distribution

  • B145114101 ()
  • B145114100 ()

  • Outer Diameter: 272 Micrometer
  • fiber core diameter


  • General/multiple surgical laser system beam guide, reusable
550 µm StripRight Fiber Strip and Scribe Tool
OPTICAL INTEGRITY INC
11388
In Commercial Distribution

  • B145114891 ()
  • B145113880 ()


  • Laser fibre stripper
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