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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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The SPUNLACE Regular Gown is a device that is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. The SPUNLACE Regular Gown is made from SPUNLACE material, and is full length, constructed with raglan sleeves, hook and loop neck closures, and tie waist closures. The gowns come with sterile.
MEDTECS (TAIWAN) CORP.
JCSG80100M
In Commercial Distribution

  • 14710415369182 ()
  • 04710415369185 ()


  • Surgical gown, single-use
The Blood Drawing Kit with Antineedle Stick Protector is a single use, sterile transfer set designed for vascular access for blood withdrawal. Use of the Needleless Access Connector allows the clinician needle-free blood withdrawal when blood sampling is required. The Antineedle Stick Protector is an integral, active safety device intended to minimize accidental needle stick injuries when used to shield needles. This device is not intended for blood transfusion.
SB-KAWASUMI LABORATORIES, INC.
BK-64A
In Commercial Distribution

BK-64A

  • Phlebotomy kit
VersaVue – Reverse Deflection Demo Scope Single The VersaVue™ Single-Use Flexible Cystoscope is a sterile, single-use, and flexible device intended to be operated with its compatible display system. The device provides endoscopic visualization to aid in diagnosis and treatment within the lower urinary tract. The Cystoscope is intended to provide visualization via displaying unit. The Cystoscope is intended for use in a hospital environment. It is designed for use in adults.
MEDIMAGING INTEGRATED SOLUTION INC.
5008
In Commercial Distribution

  • 04719872715184 ()
  • 04719872715191 ()
M0067801522

  • Flexible video cystoscope, single-use
VersaVue - Standard Deflection Demo Scope Single The VersaVue™ Single-Use Flexible Cystoscope is a sterile, single-use, and flexible device intended to be operated with its compatible display system. The device provides endoscopic visualization to aid in diagnosis and treatment within the lower urinary tract. The Cystoscope is intended to provide visualization via displaying unit. The Cystoscope is intended for use in a hospital environment. It is designed for use in adults.
MEDIMAGING INTEGRATED SOLUTION INC.
5008
In Commercial Distribution

  • 04719872715160 ()
  • 04719872715177 ()
M0067801022

  • Flexible video cystoscope, single-use
VersaVue - Reverse Deflection Scope Single The VersaVue™ Single-Use Flexible Cystoscope is a sterile, single-use, and flexible device intended to be operated with its compatible display system. The device provides endoscopic visualization to aid in diagnosis and treatment within the lower urinary tract. The Cystoscope is intended to provide visualization via displaying unit. The Cystoscope is intended for use in a hospital environment. It is designed for use in adults.
MEDIMAGING INTEGRATED SOLUTION INC.
5008
In Commercial Distribution

  • 04719872715139 ()
  • 04719872715153 ()
M0067801510

  • Flexible video cystoscope, single-use
VersaVue - Standard Deflection Scope Single The VersaVue™ Single-Use Flexible Cystoscope is a sterile, single-use, and flexible device intended to be operated with its compatible display system. The device provides endoscopic visualization to aid in diagnosis and treatment within the lower urinary tract. The Cystoscope is intended to provide visualization via displaying unit. The Cystoscope is intended for use in a hospital environment. It is designed for use in adults.
MEDIMAGING INTEGRATED SOLUTION INC.
5008
In Commercial Distribution

  • 04719872715047 ()
  • 04719872715146 ()
M0067801010

  • Flexible video cystoscope, single-use
A hand-held manual instrument designed primarily for non-dedicated grasping of devices, sponges and/or dressings during a procedure; it is neither intended for tissue manipulation nor endoscopic use. It typically has a tweezers-like design with two blades joined at the proximal (non-working) end with variously designed tips at the working end. It is made of metal and/or plastic materials and is available in various sizes. This is a single-use device.
MEED SKILL SURGICAL
MSS71023A
In Commercial Distribution

  • G429MSS71023A0 ()
MSS71023A

  • Dressing/utility forceps, tweezers-like, single-use
A flexible manual device intended to be used in combination with a compatible endoscope to grasp foreign bodies. It is constructed of a flexible metal coil and plastic tube whose distal end is equipped with grasping tongs which are operated by a control handle attached at the proximal end of the instrument. It is introduced into the body cavity through the working channel of the endoscope. This is a single-use device.
HOBBS MEDICAL, INC.
5030S
In Commercial Distribution

  • M8495030S0 ()
  • M8495030S1 ()
5030S

  • Flexible endoscopic tissue manipulation forceps, single-use
A flexible manual device intended to be used in combination with a compatible endoscope to grasp foreign bodies. It is constructed of a flexible metal coil and plastic tube whose distal end is equipped with grasping tongs which are operated by a control handle attached at the proximal end of the instrument. It is introduced into the body cavity through the working channel of the endoscope. This is a single-use device.
HOBBS MEDICAL, INC.
5030
In Commercial Distribution

  • M84950300 ()
5030

  • Flexible endoscopic tissue manipulation forceps, single-use
A flexible manual device intended to be used in combination with a compatible endoscope to grasp foreign bodies. It is constructed of a flexible metal coil and plastic tube whose distal end is equipped with grasping tongs which are operated by a control handle attached at the proximal end of the instrument. It is introduced into the body cavity through the working channel of the endoscope. This is a reuseable device.
HOBBS MEDICAL, INC.
5018
In Commercial Distribution

  • M84950180 ()
5018

  • Flexible endoscopic tissue manipulation forceps, reusable
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