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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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Everlywell Urine Collection Kit - G7324001

No Description
Everly Health, Inc.
5
In Commercial Distribution

  • G7324001 ()


  • Urine specimen collection kit IVD

VasQ - 07290016063356

External support for vascular access arteriovenous fistulas
LAMINATE MEDICAL TECHNOLOGIES LTD
5
In Commercial Distribution

  • 07290016063356 ()
FG0035

  • Arteriovenous fistula extraluminal mesh-sleeve

Radmedix AccuVue+ - 00810035220379

A software application to facilitate management, distribution, and/or viewing of radiological digital imaging and communications in medicine (DICOM) image data, Including functions for viewing, communication, printing, recording/ disc burning and/or image manipulation.
RADMEDIX, LLC
5
In Commercial Distribution

  • 00810035220379 ()


  • Radiology DICOM image processing application software

Fivos PACS - B159FIVOSPACS0

No Description
Fivos, Inc.
5
Not in Commercial Distribution

  • B159FIVOSPACS0 ()


  • Radiological PACS software

Baru - 16975783730028

No Description
Baru Foshan medical technology co., Limited
5
In Commercial Distribution

  • 06975783730021 ()
  • 16975783730028 ()


  • Dental cotton roll

Chemoment - 06976009585555

No Description
Chemoment Materials Co., Ltd.
5
In Commercial Distribution

  • 06976009585555 ()


  • Silicone dental impression material

N/A - 00810050243308

KIT, SMALL, "B". Includes: 112 - DISC, CIRCULAR, 7” DIAMETER x 1.5” (00810050241175), 114 - RECTANGLE, 2” x 7.5” x 9.5” (00810050241649), 116 - WEDGE, 3” x 4” x 7” (10810050242964), 117 - WEDGE, 2.5” x 7” x 10” (10810050242933), 118 - WEDGE, 7” x 7” x 7” (00810050242387), 121 - BLOCK, OBLIQUE FINGER, 3.13” x 5.5” x 5” (00810050241052)
DOMICO MED-DEVICE, LLC
5
In Commercial Distribution

  • 00810050243308 ()


  • Multifunction body cushion
  • Radiological general body-part positioner

OTS Hip Guide SW - 07350137520029

No Description
Ortoma AB (Publ)
5
In Commercial Distribution

  • 07350137520029 ()
20-100

  • Electromagnetic/optical surgical navigation device tracking system

OTS Hip Plan - 07350137520005

No Description
Ortoma AB (Publ)
5
In Commercial Distribution

  • 07350137520005 ()
20-101

  • Surgical planning/navigation-enhancement system

Movement and Compressions System (MAC) - B547RF14210

MAC Strap-XL
Recovery Force, LLC
5
In Commercial Distribution

  • B547RF14217 ()
  • B547RF14210 ()
  • B547RF1440219 ()

  • Length: 743 Millimeter
RF1421

  • Intermittent venous compression system
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