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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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Traxi Panniculus Retractor with Retentus Technology (BMI 30-50)
CLINICAL INNOVATIONS, LLC
PRS-0530
In Commercial Distribution

  • 30814247020346 ()
  • 40814247020343 ()


  • Abdominal retractor, hand-held
ARYS pro is intended to track and organize patient health and activity information recorded by sensors on the paretic and healthy wrist and using a mobile app for visualization.
tyromotion GmbH
3
In Commercial Distribution

  • 09120077180120 ()


  • Biomechanical function analysis/rehabilitation software
Extra-Wide, Adjustable Height Armboard (SWISS)
SCHUERCH CORPORATION
800-0017-SWISS
In Commercial Distribution

  • 00810057373046 ()
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#

  • Arm procedure positioner, reusable
Suji device for BFR training. Suji comprises of a BLE enable pump, compression bands and a mobile app. The compression bands are worn at the top of the limb to restrict blood flow during exercise.
SECONDPERSPECTIVE LTD.
V2MDR-01
In Commercial Distribution

  • 05070000320403 ()


  • Tourniquet cuff, reusable
Scale, Digital Home Health Model DHH-10BT 440lb (200kg) x0.2lb (0.1kg) 300mm (L) x 360mm (W) x 8mm (H) includes (2) AAA batteries, tempered glass Includes Bluetooth connectivity compatible with Apple Health and Google Health APP
Rice Lake Weighing Systems, Inc.
DHH-10BT
In Commercial Distribution

  • 00850042373255 ()
201125

  • Stand-on floor scale, electronic
Thermidas VistaClinic Analyzer is a software app for the analysis of images that have been captured with Thermidas IRT-384 Tablet. The tools include adjustment of color scale, use of regions of interest, zoom & pan, and annotations.
TherMidas Oy
Thermidas VistaClinic Analyzer
In Commercial Distribution

  • 06429810718044 ()
ThAnalyzer

  • Infrared thermography system
LEGGINGS MAMAN 70 OPAQUE, SIZE M, MOKA, GRADUATED COMPRESSION 12/15 mmHg OPAQUE LEGGINGS FOR EXPECTANT MOhttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#THERS WITH A POUCH AND A SUPPORTING BAND SUITABLE FOR THE GROWING BELLY
CALZIFICIO PINELLI SRL
057611
In Commercial Distribution

  • 08300496057611 ()
048670

  • Compression/pressure tubular garment
"An absorbent paper points is an endodontic paper point that is used during the endodontic therapy to dry, or remove any foreign materials from the root canal of a tooth." https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#
DiaDent Group International
ISO 10
In Commercial Distribution

  • 08806383516815 ()
256-502

  • Endodontic paper point
"An absorbent paper points is an endodontic paper point that is used during the endodontic therapy to dry, or remove any foreign materials from the root canal of a tooth." https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#
DiaDent Group International
ISO 45
In Commercial Distribution

  • 08806383528894 ()
MP201-309

  • Endodontic paper point
Matrx MAC-HUG Back Support. 300lb. Weight Capacity. Each Matrx MAC-HUG Backs come with two configurable MAC Lateral Contour Supports (available in 3 optional contour depths) to allow for precise orientation within the wheelchair for optimal positioning and postural support. The MAC-HUG Back incorporates our unique StaminaFibre ® insert for maximum immersion/envelopment and increased comfort.https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#
Motion Concepts Inc
MAC-HUG
In Commercial Distribution

  • 07540147001391 ()
MACwwhh-HUG

  • Wheelchair back rest
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