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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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Spex Limited - 09420082600706

Constructa Shape Cushion for United States, 16" Wide x 18" Deep, High Contour with Wipedown Cover. Includes Strategic Positioning Kit
SPEX LIMITED
1102-1618-SHC
In Commercial Distribution

  • 09420082600706 ()


  • Wheelchair seat cushion

Spex Limited - 09420082600584

Constructa Shape Cushion for United States, 16" Wide x 16" Deep, High Contour with Wipedown Cover. Includes Strategic Positioning Kit
SPEX LIMITED
1102-1616-SHC
In Commercial Distribution

  • 09420082600584 ()


  • Wheelchair seat cushion

Spex Limited - 09420082600454

Constructa Shape Cushion for United States, 14" Wide x 18" Deep, High Contour with Wipedown Cover. Includes Strategic Positioning Kit
SPEX LIMITED
1102-1418-SHC
In Commercial Distribution

  • 09420082600454 ()


  • Wheelchair seat cushion

Spex Limited - 09420082600140

Constructa Shape Cushion for United States, 14" Wide x 14" Deep, High Contour with Wipedown Cover. Includes Strategic Positioning Kit
SPEX LIMITED
1102-1414-SHC
In Commercial Distribution

  • 09420082600140 ()


  • Wheelchair seat cushion

For Wild - 00848340020209

Micro Kover
ADVANCE MEDICAL DESIGNS, INC.
09-MK954
In Commercial Distribution

  • 10848340020206 ()
  • 00848340020209 ()


  • Medical equipment/instrument drape, single-use

Fusion Bx - 00628055858010

Fusion Bx 2.0 is designed to display the 2D live video received from commercially available ultrasound machines and use this 2D video to reconstruct a 3D ultrasound image volume. The system is designed to work with clinicians’ existing ultrasound machines, transrectal ultrasound (TRUS) probes, commercially available needles, needle guides/templates and needle gun combination. Additional software features include patient data management, multi-planar reconstruction, segmentation, image measurements and 3D image registration. Fusion Bx 2.0 offers the physician additional 3D information for assessing prostate abnormalities, planning and implementing biopsy procedures. The additional image processing features are generated with minimal changes to previous TRUS probe-based procedures, and the physician always has access to the live 2D ultrasound image during prostate assessment or biopsy procedure.
Focal Healthcare Inc
2.0
In Commercial Distribution

  • 00628055858010 ()


  • Radiology picture archiving and communication system workstation

Bio Protech - 00817120021408

HiDow Rectangular Shape Tens Electrodes (2x3in BP Gel)- 2 pcs per pack/pouch, Multi use self-adhesive electrodes,Tens Electrodes with BP Gel (Rectangle shape)
BIO PROTECH USA, INC.
HiDow Rectangular Shape Tens Electrodes (2x3in BP Gel)
In Commercial Distribution

  • 30817120021409 ()
  • 20817120021402 ()
  • 10817120021405 ()
  • 00817120021408 ()


  • Transcutaneous electrical stimulation electrode, single-use

RESECTION MASTER - 04055207019092

HOOK ELECTRODE MONO/BIPO 27FR for hysteroscopy, for sheaths with chip suction, 27, Fr, electrode shape: hook, PACK=1 PC, for use in combination with the Resection Master resectoscope, unsterile, reusable
Richard Wolf GmbH
8659163
Not in Commercial Distribution

  • 04055207019092 ()

  • Outer Diameter: 9 Millimeter
8659163

  • Endoscopic electrosurgical electrode, monopolar, reusable

NA - 04055207017081

HOOK ELECTRODE MONO 14.5FR 0° for resectoscope, telescope Ø 2.7 mm, stem color: yellow, for sheaths, intermittent irrigation 14.5 Fr, electrode shape: hook, PACK=1 PC, for MIDI-size resectoscope, unsterile, reusable
Richard Wolf GmbH
8416091
In Commercial Distribution

  • 04055207017081 ()

  • Outer Diameter: 4.83333333333 Millimeter
  • Angle: 0 degree
8416091

  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable

Clamp-On Transducer - 04062114000099

Clamp-on Transducer: The SonoTT Clamp-on Transducer measures flow in extracorporeal tubing systems. The sensor is clamped on to the tubing by a simple click closure device and measurements are made non-invasively. The measurement method can be used for extracorporeal circulation systems such as heart-lung machines or ECMO/ECLS applications. The sensors are available in different sizes for all conventional tubing sizes. A customer-specific calibration of the sensor guarantees the highest measurement precision and complete reliability.
em-tec GmbH
12132
Not in Commercial Distribution

  • 04062114000099 ()
12132

  • Noninvasive vascular ultrasound system, line-powered
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