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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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Biosensor Patch - Electrocardiography Telemetric Monitoring Patch
Lifesignals, Inc.
CV1245
Not in Commercial Distribution

  • B353CV12452 ()
  • B353CV12451 ()
  • B353CV12453 ()


  • Electrocardiography telemetric monitoring system
Biosensor Patch - Electrocardiography Telemetric Monitoring Patch
Lifesignals, Inc.
CS1245
Not in Commercial Distribution

  • B353CS124502 ()
  • B353CS124501 ()
  • B353CS124503 ()


  • Electrocardiography telemetric monitoring system
2A Wearable Biosensor
Lifesignals, Inc.
UB2550
In Commercial Distribution

  • B353UB25502 ()
  • B353UB25501 ()
  • B353UB25503 ()


  • Wearable multiple physiological parameter recorder, single-use
2AYe Wearable Biosensor
Lifesignals, Inc.
UB2251
In Commercial Distribution

  • B353UB22512 ()
  • B353UB22511 ()
  • B353UB22513 ()


  • Electrocardiographic ambulatory recorder
1AX Wearable Biosensor
Lifesignals, Inc.
UB1550
In Commercial Distribution

  • B353UB15501 ()
  • B353UB15502 ()
  • B353UB15503 ()


  • Wearable multiple physiological parameter recorder, single-use
Myriad Matrix™ is an intact extracelluar matrix (ECM) derived from ovine (sheep) forestomach tissue. This advanced ECM scaffold is non-reconstituted collagen, thus it retains the innate biological structure and function of the native ECM associated macromolecules including elastin, fibronectin, glycosaminoglycans and laminin. Myriad Matrix transforms into a soft conforming sheet, which is incorporated into the surrounding tissue over time. The device is supplied sterile and dry in a variety of sizes and thicknesses, which can be trimmed to size or applied whole to meet the individual patient's needs.
AROA BIOSURGERY LIMITED
SR05LG0505US
In Commercial Distribution

  • 09421906017625 ()

  • 5 x 5 cm, 5 Layer


  • Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial
  • Animal-derived wound matrix dressing
No Description
Zimmer, Inc.
42-5574-058-05
In Commercial Distribution

  • 00889024561113 ()

  • Size 5, 5+, 5 mm, Thickness
42-5574-058-05

  • Knee arthroplasty wedge
No Description
Zimmer, Inc.
42-5572-058-05
In Commercial Distribution

  • 00889024560925 ()

  • Size 5, 5+, 5 mm, Thickness
42-5572-058-05

  • Knee arthroplasty wedge
No Description
Zimmer, Inc.
42-5568-058-05
In Commercial Distribution

  • 00889024556911 ()

  • Size 5, 5+, 5 mm, Thickness
42-5568-058-05

  • Knee arthroplasty wedge
No Description
Zimmer, Inc.
42-5566-058-05
In Commercial Distribution

  • 00889024556720 ()

  • Size 5, 5+, 5 mm, Thickness
42-5566-058-05

  • Knee arthroplasty wedge
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