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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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DURA 62106 SUBSTITUTE DUREPAIR 1X3IN NCE
MEDTRONIC PS MEDICAL, INC.
62106
Not in Commercial Distribution

  • 00643169063877 ()

  • Length: 7.5 Centimeter
  • Width: 2.5 Centimeter


  • Dura mater graft, bovine
DURA 62105 SUBSTITUTE DUREPAIR 3X3IN NCE
MEDTRONIC PS MEDICAL, INC.
62105
Not in Commercial Distribution

  • 00643169063860 ()

  • Width: 7.5 Centimeter
  • Length: 7.5 Centimeter


  • Dura mater graft, bovine
DURA 62100 SUBSTITUTE DUREPAIR 2X2IN NCE
MEDTRONIC PS MEDICAL, INC.
62100
Not in Commercial Distribution

  • 00643169063853 ()

  • Width: 5.0 Centimeter
  • Length: 5.0 Centimeter


  • Dura mater graft, bovine
Pharmacy refrigerator/ freezer
B Medical Systems SARL
PF260
In Commercial Distribution

  • 05450104548390 ()
991.8346.**

  • Pharmacy refrigerator/freezer, mains-powered
Laboratory refrigerator/ freezer
B Medical Systems SARL
LF260
In Commercial Distribution

  • 05450104548383 ()
991.8346.**

  • Laboratory refrigerator/freezer
Laboratory refrigerator/ freezer
B Medical Systems SARL
LF260
Not in Commercial Distribution

  • 05450104537714 ()
991.8346.02

  • Laboratory refrigerator/freezer
Pharmacy refrigerator/ freezer
B Medical Systems SARL
MP380CS
Not in Commercial Distribution

  • 05450104532450 ()
991.6789.52

  • Pharmacy refrigerator/freezer, mains-powered
Pharmacy refrigerator/ freezer
B Medical Systems SARL
MP380CS
In Commercial Distribution

  • 05450104519161 ()
991.6789.**

  • Pharmacy refrigerator/freezer, mains-powered
Pharmacy refrigerator/ freezer
B Medical Systems SARL
PF260
Not in Commercial Distribution

  • 05450104537721 ()
991.8346.03

  • Pharmacy refrigerator/freezer, mains-powered
Laboratory refrigerator/ freezer
B Medical Systems SARL
ML380CS
Not in Commercial Distribution

  • 05450104532443 ()
991.6789.51

  • Laboratory refrigerator/freezer
Laboratory refrigerator/ freezer
B Medical Systems SARL
ML380CS
In Commercial Distribution

  • 05450104519154 ()
991.6789.**

  • Laboratory refrigerator/freezer
Health Harmony Mobile is a component of the Health Harmony Remote Patient Monitoring system. It is a software client application that runs on a personal mobile device, used by patients to easily communicate and exchange information with their healthcare provider. The Health Harmony Mobile application collects patient responses to health assessment questions and receives patient vital signs from Bluetooth-connected medical measuring devices. The Mobile application automatically and securely transmits patient information to the provider. The Health Harmony Mobile application can also display educational material and other messages received from the provider, such as reminders encouraging patients to complete a health session or to take medications as ordered. Patients can read messages and send replies to the clinician, and may also accept or a decline a video conference call initiated by their clinician, directly from the Health Harmony Mobile application. The Enterprise version of Health Harmony Mobile is pre-loaded by the manufacturer on a personal mobile device that is provided to the patient in a Health Harmony Kit.
Care Innovations, LLC
Mobile RPM - Enterprise
Not in Commercial Distribution

  • 00850040853025 ()


  • Vulnerable patient home-monitoring software, professional-only
Health Harmony Mobile is a component of the Health Harmony Remote Patient Monitoring system. It is a software client application that runs on a personal mobile device, used by patients to easily communicate and exchange information with their healthcare provider. The Health Harmony Mobile application collects patient responses to health assessment questions and receives patient vital signs from Bluetooth-connected medical measuring devices. The Mobile application automatically and securely transmits patient information to the provider. The Health Harmony Mobile application can also display educational material and other messages received from the provider, such as reminders encouraging patients to complete a health session or to take medications as ordered. Patients can read messages and send replies to the clinician, and may also accept or a decline a video conference call initiated by their clinician, directly from the Health Harmony Mobile application. The BYOD version of Health Harmony Mobile is available for download by the patient onto their own personal mobile device.
Care Innovations, LLC
Mobile RPM - BYOD
Not in Commercial Distribution

  • 00850040853018 ()


  • Vulnerable patient home-monitoring software, professional-only
Health Harmony Maestro is a component of the Health Harmony Remote Patient Monitoring system. It is a web-based software application that is used by healthcare providers for clinical data management and communication with patients. The Health Harmony Maestro dashboard provides a snapshot of patient data including vital signs and answers to symptom and behavior questions. Patient responses and medical device readings are risk stratified based on customer and/or individual thresholds set by the clinician. Alerts display on the dashboard triage page by the most recent date. At a glance, the clinician is able to detect patient data that is outside of threshold settings. Beyond the dashboard, detailed information may be viewed at a patient level as indicated. Clinicians can send messages to the patient that will be displayed on the Health Harmony Mobile application. Video conferencing between the clinician and patient is also available within the Health Harmony applications.
Care Innovations, LLC
Maestro RPM
Not in Commercial Distribution

  • 00850040853001 ()


  • Vulnerable patient home-monitoring software, professional-only
MonitAir is a HIPAA compliant, FDA registered MDDS combining remote data monitoring and telemedicine features to support patients on PAP/NIV therapy for chronic sleep and respiratory conditions.
Monitair LLC
1.2.7
In Commercial Distribution



  • Vulnerable patient home-monitoring software, professional-only
DURA-GUARD Dural Repair Patch is prepared from bovine pericardium which is cross-linked with glutaraldehyde. The pericardium is procured from cattle originating in the United States. DURA-GUARD Dural Repair Patch is chemically sterilized using ethanol and propylene oxide. DURA-GUARD Dural Repair Patch has been treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20 - 25 C. DURA-GUARD Dural Repair Patch is packaged in a container filled with sterile, non-pyrogenic water containing propylene oxide. The contents of the unopened, undamaged container are sterile.
SYNOVIS LIFE TECHNOLOGIES, INC.
DG1016SN
In Commercial Distribution

  • 00085412531045 ()
DG1016SN

  • Dura mater graft, bovine
DURA-GUARD Dural Repair Patch is prepared from bovine pericardium which is cross-linked with glutaraldehyde. The pericardium is procured from cattle originating in the United States. DURA-GUARD Dural Repair Patch is chemically sterilized using ethanol and propylene oxide. DURA-GUARD Dural Repair Patch has been treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20 - 25 C. DURA-GUARD Dural Repair Patch is packaged in a container filled with sterile, non-pyrogenic water containing propylene oxide. The contents of the unopened, undamaged container are sterile.
SYNOVIS LIFE TECHNOLOGIES, INC.
DG0814SN
In Commercial Distribution

  • 00085412531021 ()
DG0814SN

  • Dura mater graft, bovine
DURA-GUARD Dural Repair Patch is prepared from bovine pericardium which is cross-linked with glutaraldehyde. The pericardium is procured from cattle originating in the United States. DURA-GUARD Dural Repair Patch is chemically sterilized using ethanol and propylene oxide. DURA-GUARD Dural Repair Patch has been treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20 - 25 C. DURA-GUARD Dural Repair Patch is packaged in a container filled with sterile, non-pyrogenic water containing propylene oxide. The contents of the unopened, undamaged container are sterile.
SYNOVIS LIFE TECHNOLOGIES, INC.
DG0608SN
In Commercial Distribution

  • 00085412531007 ()
DG0608SN

  • Dura mater graft, bovine
DURA-GUARD Dural Repair Patch is prepared from bovine pericardium which is cross-linked with glutaraldehyde. The pericardium is procured from cattle originating in the United States. DURA-GUARD Dural Repair Patch is chemically sterilized using ethanol and propylene oxide. DURA-GUARD Dural Repair Patch has been treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20 - 25°C. DURA-GUARD Dural Repair Patch is packaged in a container filled with sterile, non-pyrogenic water containing propylene oxide. The contents of the unopened, undamaged container are sterile.
SYNOVIS LIFE TECHNOLOGIES, INC.
DG0404SN
In Commercial Distribution

  • 00085412530987 ()
DG0404SN

  • Dura mater graft, bovine
DURA-GUARD Dural Repair Patch is prepared from bovine pericardium which is cross-linked with glutaraldehyde. The pericardium is procured from cattle originating in the United States. DURA-GUARD Dural Repair Patch is chemically sterilized using ethanol and propylene oxide. DURA-GUARD Dural Repair Patch has been treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20 - 25 C. DURA-GUARD Dural Repair Patch is packaged in a container filled with sterile, non-pyrogenic water containing propylene oxide. The contents of the unopened, undamaged container are sterile.
SYNOVIS LIFE TECHNOLOGIES, INC.
DG0209SN
In Commercial Distribution

  • 00085412530956 ()
DG0209SN

  • Dura mater graft, bovine
Collagen Dural Regeneration Matrix
COLLAGEN MATRIX, INC.
DMOC45
In Commercial Distribution

  • 00813954026114 ()

  • 4in x 5in (10cm x 12.5cm)
DMOC45

  • Dura mater graft, bovine
Collagen Dural Regeneration Matrix
COLLAGEN MATRIX, INC.
DMOC33
In Commercial Distribution

  • 00813954026107 ()

  • 3in x 3in (7.5cm x 7.5cm)
DMOC33

  • Dura mater graft, bovine
Collagen Dural Regeneration Matrix
COLLAGEN MATRIX, INC.
DMOC22
In Commercial Distribution

  • 00813954026091 ()

  • 2in x 2in (5cm x 5cm)
DMOC22

  • Dura mater graft, bovine
Collagen Dural Regeneration Matrix
COLLAGEN MATRIX, INC.
DMOC13
In Commercial Distribution

  • 00813954026084 ()

  • 1in x 3in (2.5cm x 7.5cm)
DMOC13

  • Dura mater graft, bovine
No Description
COLLAGEN MATRIX, INC.
DMOC11
In Commercial Distribution

  • 00813954026077 ()

  • 1in x 1in (2.5cm x 2.5cm)
DMOC11

  • Dura mater graft, bovine
Dural Graft Implant
COLLAGEN MATRIX, INC.
DFCS45
In Commercial Distribution

  • 00813954025902 ()

  • 4in x 5in (10 cm x 12.5cm)
DFCS45

  • Dura mater graft, bovine
Dural Graft Implant
COLLAGEN MATRIX, INC.
DFCS33
In Commercial Distribution

  • 00813954025896 ()

  • 3in x 3in (7.5cm x 7.5cm)
DFCS33

  • Dura mater graft, bovine
Dural Graft Implant
COLLAGEN MATRIX, INC.
DFCS22
In Commercial Distribution

  • 00813954025889 ()

  • 2in x 2in (5cm x 5cm)
DFCS22

  • Dura mater graft, bovine
Dural Graft Implant
COLLAGEN MATRIX, INC.
DFCS13
In Commercial Distribution

  • 00813954025872 ()

  • 1in x 3in (2.5cm x 7.5cm)
DFCS13

  • Dura mater graft, bovine
Dural Graft Implant
COLLAGEN MATRIX, INC.
DFCS11
In Commercial Distribution

  • 00813954025865 ()

  • 1in x 1in (2.5cm x 2.5cm)
DFCS11

  • Dura mater graft, bovine
Integra® Bovine Pericardium Dural Graft is a natural, resorbable, collagenous device for use in the repair of dura mater. The device is derived from bovine pericardium and is manufactured using a multistep proprietary process which gently cleans and dehydrates the tissue. The device is terminally sterilized by gamma irradiation. The device must be sutured in place.
Integra Lifesciences Corporation
BP11216
Not in Commercial Distribution

  • M268BP112160 ()
  • 10381780074250 ()

  • Length: 12 Centimeter
  • Width: 16 Centimeter
BP11216

  • Dura mater graft, bovine
Integra® Bovine Pericardium Dural Graft is a natural, resorbable, collagenous device for use in the repair of dura mater. The device is derived from bovine pericardium and is manufactured using a multistep proprietary process which gently cleans and dehydrates the tissue. The device is terminally sterilized by gamma irradiation. The device must be sutured in place.
Integra Lifesciences Corporation
BP10812
Not in Commercial Distribution

  • M268BP108120 ()
  • 10381780074243 ()

  • Length: 8 Centimeter
  • Width: 12 Centimeter
BP10812

  • Dura mater graft, bovine
Integra® Bovine Pericardium Dural Graft is a natural, resorbable, collagenous device for use in the repair of dura mater. The device is derived from bovine pericardium and is manufactured using a multistep proprietary process which gently cleans and dehydrates the tissue. The device is terminally sterilized by gamma irradiation. The device must be sutured in place.
Integra Lifesciences Corporation
BP10608
Not in Commercial Distribution

  • M268BP106080 ()
  • 10381780074236 ()

  • Width: 8 Centimeter
  • Length: 6 Centimeter
BP10608

  • Dura mater graft, bovine
Integra® Bovine Pericardium Dural Graft is a natural, resorbable, collagenous device for use in the repair of dura mater. The device is derived from bovine pericardium and is manufactured using a multistep proprietary process which gently cleans and dehydrates the tissue. The device is terminally sterilized by gamma irradiation. The device must be sutured in place.
Integra Lifesciences Corporation
BP10405
Not in Commercial Distribution

  • M268BP104050 ()
  • 10381780074229 ()

  • Length: 4 Centimeter
  • Width: 5 Centimeter
BP10405

  • Dura mater graft, bovine
Integra® Bovine Pericardium Dural Graft is a natural, resorbable, collagenous device for use in the repair of dura mater. The device is derived from bovine pericardium and is manufactured using a multistep proprietary process which gently cleans and dehydrates the tissue. The device is terminally sterilized by gamma irradiation. The device must be sutured in place.
Integra Lifesciences Corporation
BP10207
Not in Commercial Distribution

  • M268BP102070 ()
  • 10381780074212 ()

  • Width: 7 Centimeter
  • Length: 2 Centimeter
BP10207

  • Dura mater graft, bovine
DuraGenXS Matrix Dural Regeneration Matrix is an absorbable implant for repair of dural defects. DuraGenXS Matrix is an easy to handle, soft, white, pliable, nonfriable, porous collagen matrix. DuraGenXS Matrix is supplied sterile, nonpyrogenic, for single use in double peel packages in a variety of sizes.
Integra Lifesciences Corporation
DXM1057
In Commercial Distribution

  • 10381780070993 ()
  • M269DXM10571 ()

  • 5 in x 7 in 12.5 cm x 17.5 cm
DXM1057

  • Dura mater graft, bovine
DuraGenXS Matrix Dural Regeneration Matrix is an absorbable implant for repair of dural defects. DuraGenXS Matrix is an easy to handle, soft, white, pliable, nonfriable, porous collagen matrix. DuraGenXS Matrix is supplied sterile, nonpyrogenic, for single use in double peel packages in a variety of sizes.
Integra Lifesciences Corporation
DXM1045
In Commercial Distribution

  • 10381780070986 ()
  • M269DXM10451 ()

  • 4 in x 5 in 10 cm x 12.5 cm
DXM1045

  • Dura mater graft, bovine
DuraGenXS Matrix Dural Regeneration Matrix is an absorbable implant for repair of dural defects. DuraGenXS Matrix is an easy to handle, soft, white, pliable, nonfriable, porous collagen matrix. DuraGenXS Matrix is supplied sterile, nonpyrogenic, for single use in double peel packages in a variety of sizes.
Integra Lifesciences Corporation
DXM1033
In Commercial Distribution

  • 10381780070979 ()
  • M269DXM10331 ()

  • 3 in x 3 in 7.5 cm x 7.5 cm
DXM1033

  • Dura mater graft, bovine
DuraGenXS Matrix Dural Regeneration Matrix is an absorbable implant for repair of dural defects. DuraGenXS Matrix is an easy to handle, soft, white, pliable, nonfriable, porous collagen matrix. DuraGenXS Matrix is supplied sterile, nonpyrogenic, for single use in double peel packages in a variety of sizes.
Integra Lifesciences Corporation
DXM1022
In Commercial Distribution

  • 10381780070962 ()
  • M269DXM10221 ()

  • 2 in x 2 in 5 cm x 5 cm
DXM1022

  • Dura mater graft, bovine
DuraGenXS Matrix Dural Regeneration Matrix is an absorbable implant for repair of dural defects. DuraGenXS Matrix is an easy to handle, soft, white, pliable, nonfriable, porous collagen matrix. DuraGenXS Matrix is supplied sterile, nonpyrogenic, for single use in double peel packages in a variety of sizes.
Integra Lifesciences Corporation
DXM1013
In Commercial Distribution

  • 10381780070955 ()
  • M269DXM10131 ()

  • 1 in x 3 in 2.5 cm x 7.5 cm
DXM1013

  • Dura mater graft, bovine
DuraGen® Plus Dural Regeneration Matrix, 3 in x 3 in (7.5 cm x 7.5 cm)
Integra Lifesciences Corporation
DP5033
In Commercial Distribution

  • 30381780070942 ()
  • 10381780070948 ()
  • M269DP50331 ()

  • 3 in x 3 in 7.5 cm x 7.5 cm
DP-5033

  • Dura mater graft, bovine
DuraGen® Plus Dural Regeneration Matrix, 2 in x 2 in (5 cm x 5 cm)
Integra Lifesciences Corporation
DP5022
In Commercial Distribution

  • 30381780070935 ()
  • 10381780070931 ()
  • M269DP50221 ()

  • 2 in x 2 in 5 cm x 5 cm
DP-5022

  • Dura mater graft, bovine
DuraGen® Plus Dural Regeneration Matrix, 1 in x 3 in (2.5 cm x 7.5 cm)
Integra Lifesciences Corporation
DP5013
In Commercial Distribution

  • 30381780070928 ()
  • 10381780070924 ()
  • M269DP50131 ()

  • 1 in x 3 in 2.5 cm x 7.5 cm
DP-5013

  • Dura mater graft, bovine
DuraGen® Plus Dural Regeneration Matrix, 1 in x 1 in (2.5 cm x 2.5 cm)
Integra Lifesciences Corporation
DP5011
In Commercial Distribution

  • 30381780070911 ()
  • 10381780070917 ()
  • M269DP50111 ()

  • 1 in x 1 in 2.5 cm x 2.5 cm
DP-5011

  • Dura mater graft, bovine
DuraGen Plus Dural Regeneration Matrix- Spinal Matrix is an absorbable implant for repair of dural defects. DuraGen Plus Dural Regeneration Matrix-Spinal Matrix is an easy to handle, soft, white, pliable, nonfriable, porous collagen matrix. DuraGen Plus Dural Regeneration Matrix-Spinal Matrix is two 1 inch x 3 inch (2.5cm x 7.5xm) dural regeneration matrices supplied sterile, non-pyrogenic, for single use in double peel packages.
Integra Lifesciences Corporation
51100213
Not in Commercial Distribution

  • 10381780070726 ()
  • 00381780070729 ()
  • M269511002131 ()

  • 1 inch x 3 inch (2.5cm x 7.5cm)
51100213

  • Dura mater graft, bovine
DuraGen® Dural Graft Matrix 4 in x 5 in (10cm x12.5cm)
Integra Lifesciences Corporation
ID4501
In Commercial Distribution

  • 10381780023616 ()
  • M269ID45011 ()

  • 4 in x 5 in 10 cm x 12.5 cm
ID4501

  • Dura mater graft, bovine
DuraGen® Plus Dural Regeneration Matrix, 5 in x 7 in (12.5 cm x 17.5 cm)
Integra Lifesciences Corporation
DP1057
In Commercial Distribution

  • 10381780023487 ()
  • M269DP10571 ()

  • 5 in x 7 in 12.5 cm x 17.5 cm
DP-1057

  • Dura mater graft, bovine
DuraGen® Plus Dural Regeneration Matrix , 4 in x 5 in
Integra Lifesciences Corporation
DP1045
In Commercial Distribution

  • 10381780023470 ()
  • M269DP10451 ()

  • 4 in x 5 in 10 cm x 12.5 cm
DP-1045

  • Dura mater graft, bovine
Durepair™ 7.5cm x 7.5cm (3" x 3")
TEI BIOSCIENCES INC.
62105
In Commercial Distribution


  • Width: 3 Inch
  • Length: 7.5 Centimeter
  • Length: 3 Inch
  • Width: 7.5 Centimeter
62105

  • Dura mater graft, bovine
Durepair™ 5.0cm x 5.0cm (2" x 2")
TEI BIOSCIENCES INC.
62100
In Commercial Distribution


  • Length: 5 Centimeter
  • Length: 2 Inch
  • Width: 2 Inch
  • Width: 5 Centimeter
62100

  • Dura mater graft, bovine
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