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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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N/A - 04961333243358

REUSE BRUSH 6.0BRISTLE 300L 4.2MAX 2PC
PENTAX OF AMERICA, INC.
KUMCS-6030SNK
In Commercial Distribution

  • 04961333243358 ()
  • 14961333243355 ()

  • Outer Diameter: 6.0 Millimeter
  • Length: 300.0 Centimeter


  • Endoscope cleaning brush, reusable

N/A - 04961333243341

REUSE BRUSH 6.0BRISTLE 210L 4.8MAX 2PC
PENTAX OF AMERICA, INC.
KUMCS-6021SNK
In Commercial Distribution

  • 04961333243341 ()
  • 14961333243348 ()

  • Lumen/Inner Diameter: 4.8 Millimeter
  • Outer Diameter: 6.0 Millimeter
  • Length: 210.0 Centimeter


  • Endoscope cleaning brush, reusable

N/A - 04961333243310

REUSE BRUSH 3.0BRISTLE 300L 1.8MAX 2PC
PENTAX OF AMERICA, INC.
KUMCS-3030SK
In Commercial Distribution

  • 04961333243310 ()
  • 14961333243317 ()

  • Lumen/Inner Diameter: 1.8 Millimeter
  • Outer Diameter: 3.0 Millimeter
  • Length: 300.0 Centimeter


  • Endoscope cleaning brush, reusable

N/A - 04961333243303

CLEANING BRUSHES 2 PER PACK
PENTAX OF AMERICA, INC.
KUMCS-3025SK
In Commercial Distribution

  • 04961333243303 ()
  • 14961333243300 ()

  • Lumen/Inner Diameter: 1.8 Millimeter
  • Outer Diameter: 3.0 Millimeter
  • Length: 250.0 Centimeter


  • Endoscope cleaning brush, reusable

N/A - 04961333242849

REUSABLE CLEANING BRUSH 2/PK
PENTAX OF AMERICA, INC.
CS-6021SNK
In Commercial Distribution

  • 04961333242849 ()
  • 14961333242846 ()

  • Lumen/Inner Diameter: 4.8 Millimeter
  • Outer Diameter: 6.0 Millimeter
  • Length: 210.0 Centimeter


  • Endoscope cleaning brush, reusable

Tenscare - 05033435134458

The Sure + is intended to provide electrical stimulation and neuromuscular re-education for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge, and mixed urinary incontinence in women and to maintain urinary continence in women. The Sure + is intended for OTC use.
TENSCARE LIMITED
Sure+
In Commercial Distribution

  • 05033435134458 ()
K-SURE+USA

  • Perineal orifice incontinence-control electrical stimulation system

TensCare - 05033435134021

The Kegel Toner is a powered muscle stimulator used for strengthening the pelvic floor muscles. The Kegel Toner is intended to provide electrical stimulation and neuromuscular re-education for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress incontinence in women.
TENSCARE LIMITED
Kegel Toner
In Commercial Distribution

  • 05033435134021 ()
K-KT

  • Perineal orifice incontinence-control electrical stimulation system

EmbaGYN - 05033435132171

EmbaGYN Pelvic Floor Exerciser is a portable, battery operated electrical muscle stimulator. EmbaGYN is indicated for the rehabilitation and strengthening of weak pelvic floor muscles in the treatment of stress, urge, and mixed urinary incontinence. It is designed to be extremely easy to use, and is intended for daily use by the patient in their own home. The EmbaGYN is supplied with a Liberty vaginal electrode that may not be sterilised and is intended for single patient use.
TENSCARE LIMITED
itouch Sure
In Commercial Distribution

  • 05033435132171 ()
K-EMBAGYN

  • Perineal orifice incontinence-control electrical stimulation system

Tenscare Kegelfit Pelvic Floor Exerciser - 05033435132089

The Kegelfit is intended to provide electrical stimulation and neuromuscular re-education for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress incontinence in women. The Kegelfit is a powered muscle stimulator used for strengthening the pelvic floor muscles. It sends a gentle stimulation (similar to your natural nerve impulses) direct to your pelvic floor muscles through a vaginal Trainer with stainless steel electrodes. These signals make your pelvic floor muscle contract. If you have forgotten how to contract your pelvic floor, are having trouble getting muscle response, or simply want to bring back the condition of your pelvic floor muscles, the Kegelfit can work them for you to build up their strength and help you to develop your own muscle control. It perfectly complements pelvic floor exercises. The kegelfit is very easy to use, with two preset training programs, two choices of exercise time and simple push button control. Stimulator, Electrical, Non-implantable, for Incontinence – Title 21, Code of Federal Regulations Sec.876.5320 ProCode: KPI Regulation Number: 21 CFR 876.5320 Regulatory Class: II
TENSCARE LIMITED
KegelFit2
In Commercial Distribution

  • 05033435132089 ()
K-KEGEL

  • Perineal orifice incontinence-control electrical stimulation system

8000 Series Reusable Channel Cleaning Brush - 00666416110124

Reusable Channel Cleaning Micro Brush. HIBC/UPN: M45387030
Primed Instruments Inc
8703
In Commercial Distribution

  • 00666416110124 ()

  • Minimum Channel Size: 1.0mm
  • Brush Diameter: 2.3mm
  • Working Length: 165cm
8703

  • Endoscope cleaning brush, reusable
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