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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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wemade - 06938799200131

No Description
Wuxi Wemade Healthcare Products Co., Ltd.
5CM X 450CM
In Commercial Distribution

  • 06938799200131 ()


  • Skin treatment/dressing-supportive limb/finger bandage, single-use

TE X Lite Diagnostic Ultrasound System - 06903053003919

No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
TE X Lite
In Commercial Distribution

  • 06903053003919 ()


  • General-purpose ultrasound imaging system

WEGO-PGLA Absorbable Surgical Suture With Needle - 06941813621805

No Description
Foosin Medical Supplies Inc., Ltd.
A3-45 x 6
In Commercial Distribution

  • 06941813626800 ()
  • 06941813621805 ()


  • Polyester suture, bioabsorbable, multifilament, non-antimicrobial

WEGO-PGLA Absorbable Surgical Suture With Needle - 06941813621799

No Description
Foosin Medical Supplies Inc., Ltd.
A4-45 x 6
In Commercial Distribution

  • 06941813626794 ()
  • 06941813621799 ()


  • Polyester suture, bioabsorbable, multifilament, non-antimicrobial

Tergazyme - 00660483130597

Cleaner for ultrasonic cleaning of medical devices
ALCONOX INC
.5 x 500
In Commercial Distribution

  • 00660483130597 ()
1305

  • Medical device cleaning agent

X-ray Imaging System (XIS) - 00866854000401

The X-ray Imaging System controls the x-ray generation, image processing and patient registration of the McLaren Proton Treatment System. The software product described by this document is considered a sub-system of the MPTS. The software product integrates with the following components of the MPTS system: • X-ray generator & tube assembly • Amorphous silicon flat-panel detector • Electro-mechanical controls of the imaging c-ring to enable system positioning and rotation around the patient The software will permit a radiation technician to set the desired energy levels and field of view. Once set the software can acquire orthogonal or CBCT x-ray images of the region of interest. When images are acquired the software will process them to create viewable images for patient location registration. The patient location registration workflow will locate the treatment isocenter, defined in the patient anatomy, relative to the desired position in the treatment room through which the beam passes. The location of the treatment isocenter is established during treatment planning with 3D planning images (CT simulation images). The patient’s position will be adjusted, if needed, based on a comparison of the current patient location, the defined treatment plan, and previously acquired Digitally Reconstructed Radiographs or CTs. There are two defined methods of registration, 1. Digitally Reconstructed Radiographs (DRRs) from 3D planning images are compared to the 2D images taken during patient setup in order to compare the patient anatomy with the expected location and orientation given by the DRRs. The registration tool is implemented to display both the downloaded DRRs, provided by the treatment planning system, and the display of the new 2D images, acquired by x-ray imaging system. 2. 3D planned volume images are compared to the CBCT volumetric (CTs) images taken during patient setup in order to compare the patient anatomy with the expected location and orientation. The regis
EhmetDx LLC
v.1.x
In Commercial Distribution

  • 00866854000401 ()
n/a

  • CT system application software

MEBO Would Dressing - 00860005367542

The MEBO Wound Dressing is a C060 gamma-adiation sterilized dressing consisting of sesame oi, beeswax and fabric dressing, which provides a moist environment for optimal wound healing.
Mebo Life Science Inc.
40mm x 60mm
In Commercial Distribution

  • 00860005367542 ()


  • Wound-nonadherent dressing, absorbent, non-antimicrobial

MEBO Would Dressing - 00860005367535

The MEBO Wound Dressing is a C060 gamma-adiation sterilized dressing consisting of sesame oi, beeswax and fabric dressing, which provides a moist environment for optimal wound healing
Mebo Life Science Inc.
60mm x 120mm
In Commercial Distribution

  • 00860005367535 ()


  • Wound-nonadherent dressing, absorbent, non-antimicrobial

ConvertX™ Nephroureteral Stent System - 00851571007505

No Description
BRIGHTWATER MEDICAL, INC.
10.3F x 14cm
Not in Commercial Distribution

  • 00851571007505 ()

  • Length: 14 Centimeter
  • Catheter Gauge: 10.3 French
120010-14

  • Polymeric ureteral stent

ConvertX™ Nephroureteral Stent System - 00851571007499

No Description
BRIGHTWATER MEDICAL, INC.
10.3F x 12cm
Not in Commercial Distribution

  • 00851571007499 ()

  • Length: 12 Centimeter
  • Catheter Gauge: 10.3 French
120010-12

  • Polymeric ureteral stent
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