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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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ARCHITECT HIV Ag/Ab Combo Reagent Kit
Abbott GmbH
2P36-25
In Commercial Distribution

  • 00380740003890 ()
02P3625

  • HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay
ARCHITECT HIV Ag/Ab Combo Reagent Kit
Abbott GmbH
2P36-35
In Commercial Distribution

  • 00380740003906 ()
02P3635

  • HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay
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
Wearable Biosensor - ECG Remote Monitoring Biosensor Patch
Lifesignals, Inc.
MM1250
Not in Commercial Distribution

  • B353MM12501 ()
  • B353MM12502 ()
  • B353MM12503 ()


  • Electrocardiography telemetric monitoring system
Wearable Biosensor - ECG Remote Monitoring Biosensor Patch
Lifesignals, Inc.
LP1250
Not in Commercial Distribution

  • B353LP12502 ()
  • B353LP12501 ()
  • B353LP12503 ()


  • Electrocardiographic ambulatory recorder
Biosensor Patch - Electrocardiography Telemetric Monitoring Patch
Lifesignals, Inc.
LP1110
Not in Commercial Distribution

  • B353LP11103 ()
  • B353LP11102 ()
  • B353LP11101 ()


  • Electrocardiography telemetric monitoring system
Biosensor Patch - Electrocardiography Telemetric Monitoring Patch
Lifesignals, Inc.
IM1210
Not in Commercial Distribution

  • B353IM12103 ()
  • B353IM12102 ()
  • B353IM12101 ()


  • Electrocardiography telemetric monitoring system
Biosensor Patch - Electrocardiography Telemetric Monitoring Patch
Lifesignals, Inc.
IM1110
Not in Commercial Distribution

  • B353IM11103 ()
  • B353IM11102 ()
  • B353IM11101 ()


  • Electrocardiography telemetric monitoring system
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
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
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
Scribe Opco, Inc.
Kit 5
In Commercial Distribution

  • 00850013750221 ()


  • First aid kit, medicated
Bathmate Xersizer 5
DX PRODUCTS LIMITED
Xersizer 5
In Commercial Distribution

  • 05060140208563 ()

  • Lumen/Inner Diameter: 1.8 Inch
  • Depth: 5 Inch
XZ-S5

  • Penile vacuum device
Hybrid Lubricant is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
GOOD CLEAN LOVE, INC.
5 mL
In Commercial Distribution

  • 30850014621781 ()
  • 00850014621780 ()
  • 00850044065042 ()
200501

  • Sexual lubricant
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