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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, 1-wall needle
PROCEDURE PRODUCTS, INC.
329-355
In Commercial Distribution

  • B1603293552 ()
  • B1603293551 ()


  • Vascular catheter introduction needle
NEEDLE, W/O BASEPLATE 5.7CM 18g
PROCEDURE PRODUCTS, INC.
31-1822
In Commercial Distribution

  • B1603118222 ()
  • B1603118221 ()


  • Vascular catheter introduction needle
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
Not 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)
Not 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
The device is a configurable, manual surgical aid accessory with multi-modality fiducial markers and a needle guide grid for image-guided transperineal procedures. The device is intended to guide needle placements while keeping the patient's perineum accessible during endorectal ultrasound and MR/CT-guided interventions. The device is intended for use in a clinical setting. The device constitutes 3 pairs of posts (T, M, S) as a replacement for Clear Guide TP Access Tool (CG-PAT).
CLEAR GUIDE MEDICAL, INC.
CGTPP
In Commercial Distribution

  • B201CGTPP0 ()
  • B201CGTPP1 ()

  • Length: 3 Inch
  • Length: 4 Inch
  • Length: 5 Inch
CG-TPP

  • MRI-oriented needle guide positioner
The device is a configurable, manual surgical aid accessory with multi-modality fiducial markers and a needle guide grid for image-guided transperineal procedures. The device is intended to guide needle placements while keeping the patient's perineum accessible during endorectal ultrasound and MR/CT-guided interventions. The device is intended for use in a clinical setting. The device is a guide frame replacement for the Clear Guide TP Access Tool (CG-PAT).
CLEAR GUIDE MEDICAL, INC.
CGTPF
In Commercial Distribution

  • B201CGTPF0 ()
  • B201CGTPF1 ()
CG-TPF

  • MRI-oriented needle guide positioner
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