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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VASCU-GUARD is prepared from bovine pericardium cross-linked with glutaraldehyde, and treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20-25 degrees C. VASCU-GUARD is terminally sterilized using gamma irradiation. and packaged within a double-pouch system. The contents of the unopened, undamaged outer pouch are sterile.
SYNOVIS LIFE TECHNOLOGIES, INC.
VG0114
In Commercial Distribution

  • 00085412818535 ()
VG0114

  • Cardiovascular patch, animal-derived
VASCU-GUARD is prepared from bovine pericardium cross-linked with glutaraldehyde, and treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20-25 degrees C. VASCU-GUARD is terminally sterilized using gamma irradiation. and packaged within a double-pouch system. The contents of the unopened, undamaged outer pouch are sterile.
SYNOVIS LIFE TECHNOLOGIES, INC.
VG0110
In Commercial Distribution

  • 00085412818511 ()
VG0110

  • Cardiovascular patch, animal-derived
VASCU-GUARD is prepared from bovine pericardium cross-linked with glutaraldehyde, and treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20-25 degrees C. VASCU-GUARD is terminally sterilized using gamma irradiation. and packaged within a double-pouch system. The contents of the unopened, undamaged outer pouch are sterile.
SYNOVIS LIFE TECHNOLOGIES, INC.
VG0108
In Commercial Distribution

  • 00085412818498 ()
VG0108

  • Cardiovascular patch, animal-derived
VASCU-GUARD is prepared from bovine pericardium cross-linked with glutaraldehyde, and treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20-25 degrees C. VASCU-GUARD is terminally sterilized using gamma irradiation. and packaged within a double-pouch system. The contents of the unopened, undamaged outer pouch are sterile.
SYNOVIS LIFE TECHNOLOGIES, INC.
VG0106
In Commercial Distribution

  • 00085412818474 ()
VG0106

  • Cardiovascular patch, animal-derived
PERI-GUARD is prepared from bovine pericardium cross-linked with glutaraldehyde, and treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20-25 degrees C. PERI-GUARD is terminally sterilized using gamma irradiation and packaged within a double-pouch system. The contents of the unopened, undamaged outer pouch are sterile.
SYNOVIS LIFE TECHNOLOGIES, INC.
PG0608
In Commercial Distribution

  • 00085412818443 ()
PG0608

  • Cardiovascular patch, animal-derived
SUPPLE PERI-GUARD is prepared from bovine pericardium cross-linked with glutaraldehyde, and treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20-25 degrees C. SUPPLE PERI-GUARD is terminally sterilized using gamma irradiation and packaged within a double-pouch system. The contents of the unopened, undamaged outer pouch are sterile.
SYNOVIS LIFE TECHNOLOGIES, INC.
SPG1016
In Commercial Distribution

  • 00085412818429 ()
SPG1016

  • Cardiovascular patch, animal-derived
PERI-GUARD is prepared from bovine pericardium cross-linked with glutaraldehyde, and treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20-25 degrees C. PERI-GUARD is terminally sterilized using gamma irradiation and packaged within a double-pouch system. The contents of the unopened, undamaged outer pouch are sterile.
SYNOVIS LIFE TECHNOLOGIES, INC.
PG0404
In Commercial Distribution

  • 00085412818405 ()
PG0404

  • Cardiovascular patch, animal-derived
SUPPLE PERI-GUARD is prepared from bovine pericardium cross-linked with glutaraldehyde, and treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20-25 degrees C. SUPPLE PERI-GUARD is terminally sterilized using gamma irradiation and packaged within a double-pouch system. The contents of the unopened, undamaged outer pouch are sterile.
SYNOVIS LIFE TECHNOLOGIES, INC.
SPG0814
In Commercial Distribution

  • 00085412818375 ()
SPG0814

  • Cardiovascular patch, animal-derived
SUPPLE PERI-GUARD is prepared from bovine pericardium cross-linked with glutaraldehyde, and treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20-25 degrees C. SUPPLE PERI-GUARD is terminally sterilized using gamma irradiation and packaged within a double-pouch system. The contents of the unopened, undamaged outer pouch are sterile.
SYNOVIS LIFE TECHNOLOGIES, INC.
SPG0608
In Commercial Distribution

  • 00085412818313 ()
SPG0608

  • Cardiovascular patch, animal-derived
VASCU-GUARD Peripheral Vascular Patch is prepared from bovine pericardium which is cross-linked with glutaraldehyde. The pericardium is procured from cattle originating in the United States. VASCU-GUARD Peripheral Vascular Patch is chemically sterilized using ethanol and propylene oxide. VASCU-GUARD Peripheral Vascular Patch has been treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20 - 25°C. VASCU-GUARD Peripheral Vascular 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.
VG0209N
In Commercial Distribution

  • 00085412530925 ()
VG0209N

  • Cardiovascular patch, animal-derived
VASCU-GUARD Peripheral Vascular Patch is prepared from bovine pericardium which is cross-linked with glutaraldehyde. The pericardium is procured from cattle originating in the United States. VASCU-GUARD Peripheral Vascular Patch is chemically sterilized using ethanol and propylene oxide. VASCU-GUARD Peripheral Vascular Patch has been treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20 - 25°C. VASCU-GUARD Peripheral Vascular 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.
VG0110N
In Commercial Distribution

  • 00085412530918 ()
VG0110N

  • Cardiovascular patch, animal-derived
VASCU-GUARD Peripheral Vascular Patch is prepared from bovine pericardium which is cross-linked with glutaraldehyde. The pericardium is procured from cattle originating in the United States. VASCU-GUARD Peripheral Vascular Patch is chemically sterilized using ethanol and propylene oxide. VASCU-GUARD Peripheral Vascular Patch has been treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20 - 25°C. VASCU-GUARD Peripheral Vascular 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.
VG0108N
In Commercial Distribution

  • 00085412530895 ()
VG0108N

  • Cardiovascular patch, animal-derived
VASCU-GUARD Peripheral Vascular Patch is prepared from bovine pericardium which is cross-linked with glutaraldehyde. The pericardium is procured from cattle originating in the United States. VASCU-GUARD Peripheral Vascular Patch is chemically sterilized using ethanol and propylene oxide. VASCU-GUARD Peripheral Vascular Patch has been treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20 - 25 C. VASCU-GUARD Peripheral Vascular 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.
VG0106N
In Commercial Distribution

  • 00085412530871 ()
VG0106N

  • Cardiovascular patch, animal-derived
SUPPLE PERI-GUARD Repair Patch is prepared from bovine pericardium cross-linked with glutaraldehyde. The tissue, procured from cattle originating in the USA is chemically sterilized using ethanol and propylene oxide, and treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25°C. SUPPLE PERI-GUARD is MR safe.
SYNOVIS LIFE TECHNOLOGIES, INC.
PC1016SN
In Commercial Distribution

  • 00085412530710 ()
PC1016SNBIO

  • Cardiovascular patch, animal-derived
SUPPLE PERI-GUARD Repair Patch is prepared from bovine pericardium cross-linked with glutaraldehyde. The tissue, procured from cattle originating in the USA is chemically sterilized using ethanol and propylene oxide, and treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25°C. SUPPLE PERI-GUARD is MR safe.
SYNOVIS LIFE TECHNOLOGIES, INC.
PC0814SN
In Commercial Distribution

  • 00085412530697 ()
PC0814SNBIO

  • Cardiovascular patch, animal-derived
SUPPLE PERI-GUARD Repair Patch is prepared from bovine pericardium cross-linked with glutaraldehyde. The tissue, procured from cattle originating in the USA is chemically sterilized using ethanol and propylene oxide, and treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25°C. SUPPLE PERI-GUARD is MR safe.
SYNOVIS LIFE TECHNOLOGIES, INC.
PC0608SN
In Commercial Distribution

  • 00085412530673 ()
PC0608SNBIO

  • Cardiovascular patch, animal-derived
SUPPLE PERI-GUARD Repair Patch is prepared from bovine pericardium cross-linked with glutaraldehyde. The tissue, procured from cattle originating in the USA is chemically sterilized using ethanol and propylene oxide, and treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25°C. SUPPLE PERI-GUARD is MR safe.
SYNOVIS LIFE TECHNOLOGIES, INC.
PC0404SN
In Commercial Distribution

  • 00085412530642 ()
PC0404SNBIO

  • Cardiovascular patch, animal-derived
Peri-Guard Repair Patch (Peri-Guard) is a biologic tissue prepared from bovine pericardium cross-linked with glutaraldehyde. The pericardium is procured from cattle originating in the United States. Peri-Guard is chemically sterilized using ethanol and propylene oxide. Peri-Guard is treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25C.
SYNOVIS LIFE TECHNOLOGIES, INC.
PC1225N
In Commercial Distribution

  • 00085412530628 ()
PC1225NBIO

  • Cardiovascular patch, animal-derived
Peri-Guard Repair Patch (Peri-Guard) is a biologic tissue prepared from bovine pericardium cross-linked with glutaraldehyde. The pericardium is procured from cattle originating in the United States. Peri-Guard is chemically sterilized using ethanol and propylene oxide. Peri-Guard is treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25C.
SYNOVIS LIFE TECHNOLOGIES, INC.
PC1016N
In Commercial Distribution

  • 00085412530604 ()
PC1016NBIO

  • Cardiovascular patch, animal-derived
Peri-Guard Repair Patch (Peri-Guard) is a biologic tissue prepared from bovine pericardium cross-linked with glutaraldehyde. The pericardium is procured from cattle originating in the United States. Peri-Guard is chemically sterilized using ethanol and propylene oxide. Peri-Guard is treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25C.
SYNOVIS LIFE TECHNOLOGIES, INC.
PC0814N
In Commercial Distribution

  • 00085412530581 ()
PC0814NBIO

  • Cardiovascular patch, animal-derived
Peri-Guard Repair Patch (Peri-Guard) is a biologic tissue prepared from bovine pericardium cross-linked with glutaraldehyde. The pericardium is procured from cattle originating in the United States. Peri-Guard is chemically sterilized using ethanol and propylene oxide. Peri-Guard is treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25C.
SYNOVIS LIFE TECHNOLOGIES, INC.
PC0608N
In Commercial Distribution

  • 00085412530567 ()
PC0608NBIO

  • Cardiovascular patch, animal-derived
Peri-Guard Repair Patch (Peri-Guard) is a biologic tissue prepared from bovine pericardium cross-linked with glutaraldehyde. The pericardium is procured from cattle originating in the United States. Peri-Guard is chemically sterilized using ethanol and propylene oxide. Peri-Guard is treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25C.
SYNOVIS LIFE TECHNOLOGIES, INC.
PC0404N
In Commercial Distribution

  • 00085412530529 ()
PC0404NBIO

  • Cardiovascular patch, animal-derived
The Atalante X by Wandercraft is a completely self-balancing walking system for people with mobility disabilities. It is a fully powered hip-knee-ankle lower body exoskeleton with 12 actuated degrees of freedom. Atalante X is self-balancing and includes dynamic-walking control. Dynamic walking allows the Atalante X to consume significantly less power and have a more natural gait. The Atalante X is a tool for physical therapy. It is meant to be highly adjustable and be applicable for various stages of physical rehabilitation, re-mobilization and exercises.
WANDERCRAFT
ATA-002-EN US
In Commercial Distribution

  • 03665965000129 ()


  • Programmable ambulation exoskeleton, clinical
Powered walking assistance device
B-Temia Inc
5062601
In Commercial Distribution

  • 07540162060007 ()


  • Programmable ambulation exoskeleton, clinical
Powered Exoskeleton - rehabilitation institution use
REWALK ROBOTICS LTD
50-30-0001
In Commercial Distribution

  • 00861803000327 ()


  • Programmable ambulation exoskeleton, clinical
The device is a lightweight, wearable, battery-powered soft orthotic exosuit intended to be used to preform ambulatory functions in rehabilitation institutions under the supervision of a trained therapist for people with hemiplegia / hemiparesis due to stroke.
REWALK ROBOTICS LTD
50-40-0001
In Commercial Distribution

  • 00860001744507 ()


  • Programmable ambulation exoskeleton, clinical
Trexo Robotics XL Trexo Plus 1 Shipment
Trexo Robotics Inc.
A0001
In Commercial Distribution

  • 00628719321072 ()

  • XL
A001BPX

  • Programmable ambulation exoskeleton, clinical
Trexo Robotics Large Trexo Plus 1 Shipment
Trexo Robotics Inc.
A0001
In Commercial Distribution

  • 00628719321065 ()

  • Large
A001BPR

  • Programmable ambulation exoskeleton, clinical
Trexo Robotics Medium Trexo Plus 1 Shipment
Trexo Robotics Inc.
A0001
In Commercial Distribution

  • 00628719321058 ()

  • Medium
A001BPR

  • Programmable ambulation exoskeleton, clinical
Trexo Robotics Small Trexo Plus 1 Shipment
Trexo Robotics Inc.
A0001
In Commercial Distribution

  • 00628719321041 ()

  • Small
A001BPR

  • Programmable ambulation exoskeleton, clinical
60" Gait Belt, Quick Release Buckle, Natural w/ Red & Blue Stripe
Asp Global, LLC
GB60QRNRB
In Commercial Distribution

  • 00840216113978 ()


  • Gait rehabilitation system harness
SEEG DEPTH ELECTRODE, 6 MACRO AND 12 MICRO-CONTACTS PROXIMAL, EXPLORATION LENGTH 50, Ø 0.8MM
DIXI MEDICAL
MICRODEEP MICRO MACRO ELECTRODE
In Commercial Distribution

  • 03664539003894 ()

  • Macro Contact Length 2 Millimeters Macro Contact Spacing 2 Millimeters Proximal Micro Contact Exposure Diameter 0,02 Millimeters
MM08-06B51P12

  • Depth electrode
SEEG DEPTH ELECTRODE, 6 MACRO AND 12 MICRO-CONTACTS PROXIMAL, EXPLORATION LENGTH 42, Ø 0.8MM
DIXI MEDICAL
MICRODEEP MICRO MACRO ELECTRODE
In Commercial Distribution

  • 03664539003887 ()

  • Macro Contact Length 2 Millimeters Macro Contact Spacing 2 Millimeters Proximal Micro Contact Exposure Diameter 0,02 Millimeters
MM08-06B40P12

  • Depth electrode
SEEG DEPTH ELECTRODE, 6 MACRO AND 12 MICRO-CONTACTS PROXIMAL, EXPLORATION LENGTH 34, Ø 0.8MM
DIXI MEDICAL
MICRODEEP MICRO MACRO ELECTRODE
In Commercial Distribution

  • 03664539003870 ()

  • Macro Contact Length 2 Millimeters Macro Contact Spacing 2 Millimeters Proximal Micro Contact Exposure Diameter 0,02 Millimeters
MM08-06B33P12

  • Depth electrode
"SET OF 10 ANCHOR BOLTS, LENGTH 40MM, LENGTH OF THE SELF-TAPPING THREAD 10MM ACCESSORY OF MICRODEEP DEPTH ELECTRODE"
DIXI MEDICAL
ANCHOR BOLT
In Commercial Distribution

  • 03664539003733 ()
  • 03664539003689 ()

  • Length 40 Millimeters Length of the self-tapping thread 10 Millimeters
ACS-140SMS-10

  • Depth electrode
"SET OF 10 ANCHOR BOLTS, LENGTH 40MM, LENGTH OF THE SELF-TAPPING THREAD 5MM ACCESSORY OF MICRODEEP DEPTH ELECTRODE"
DIXI MEDICAL
ANCHOR BOLT
In Commercial Distribution

  • 03664539003726 ()
  • 03664539003672 ()

  • Length 40 Millimeters Length of the self-tapping thread 5 Millimeters
ACS-040SMS-10

  • Depth electrode
"SET OF 10 ANCHOR BOLTS, LENGTH 35MM,LENGTH OF THE SELF-TAPPING THREAD 10MM ACCESSORY OF MICRODEEP DEPTH ELECTRODE"
DIXI MEDICAL
ANCHOR BOLT
In Commercial Distribution

  • 03664539003719 ()
  • 03664539003665 ()

  • Length 35 Millimeters Length of the self-tapping thread 10 Millimeters
ACS-135SMS-10

  • Depth electrode
"SET OF 10 ANCHOR BOLTS, LENGTH 30MM, LENGTH OF THE SELF-TAPPING THREAD 10MM ACCESSORY OF MICRODEEP DEPTH ELECTRODE"
DIXI MEDICAL
ANCHOR BOLT
In Commercial Distribution

  • 03664539003702 ()
  • 03664539003658 ()

  • Length 30 Millimeters Length of the self-tapping thread 10 Millimeters
ACS-130SMS-10

  • Depth electrode
SET OF 10 ANCHOR BOLTS, LENGTH 25MM, LENGTH OF THE SELF-TAPPING THREAD 10MM ACCESSORY OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
ANCHOR BOLT
In Commercial Distribution

  • 03664539003696 ()
  • 03664539003641 ()

  • Length 25 Millimeters Length of the self-tapping part 10 Millimeters
ACS-125SMS-10

  • Depth electrode
TWIST DRILL FOR ANCHOR BOLT, LENGTH 250MM ACCESSORY OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
DRILL AND STOP
In Commercial Distribution

  • 03664539003535 ()
KIP-ACS-515B

  • Depth electrode
SEEG DEPTH ELECTRODE, 9 MACRO AND 8 MICRO-CONTACTS, EXPLORATION LENGTH 40,8, Ø 0.8MM
DIXI MEDICAL
MICRODEEP MICRO-MACRO ELECTRODE
In Commercial Distribution

  • 03664539003467 ()

  • " Macro Contact Length 2 Millimeters Macro Contact Spacing 4,1 Millimeters Micro Contact Exposure Diameter 0,02 Millimeters"
MM08-09A51D08

  • Depth electrode
SEEG DEPTH ELECTRODE, 6 MACRO AND 12 MICRO-CONTACTS, EXPLORATION LENGTH 50, Ø 0.8MM
DIXI MEDICAL
MICRODEEP MICRO-MACRO ELECTRODE
In Commercial Distribution

  • 03664539003450 ()

  • "Macro Contact Length 2 Millimeters Macro Contact Spacing 2 Millimeters Micro Contact Exposure Diameter 0,02 Millimeters"
MM08-06B51D12

  • Depth electrode
SEEG DEPTH ELECTRODE, 9 MACRO AND 8 MICRO-CONTACTS, EXPLORATION LENGTH 40,4, Ø 0.8MM
DIXI MEDICAL
MICRODEEP MICRO-MACRO ELECTRODE
In Commercial Distribution

  • 03664539003443 ()

  • "Macro Contact Length 2 Millimeters Macro Contact Spacing 2,8 Millimeters Micro Contact Exposure Diameter 0,02 Millimeters"
MM08-09A40D08

  • Depth electrode
SEEG DEPTH ELECTRODE, 6 MACRO AND 12 MICRO-CONTACTS, EXPLORATION LENGTH 42, Ø 0.8MM
DIXI MEDICAL
MICRODEEP MICRO-MACRO ELECTRODE
In Commercial Distribution

  • 03664539003436 ()

  • "Macro Contact Length 2 Millimeters Macro Contact Spacing 2 Millimeters Micro Contact Exposure Diameter 0,02 Millimeters"
MM08-06B40D12

  • Depth electrode
SEEG DEPTH ELECTRODE, 9 MACRO AND 8 MICRO-CONTACTS, EXPLORATION LENGTH 33,2, Ø 0.8MM
DIXI MEDICAL
MICRODEEP MICRO-MACRO ELECTRODE
In Commercial Distribution

  • 03664539003429 ()

  • "Macro Contact Length 2 Millimeters Macro Contact Spacing 1,9 Millimeters Micro Contact Exposure Diameter 0,02 Millimeters"
MM08-09A33D08

  • Depth electrode
SEEG DEPTH ELECTRODE, 6 MACRO AND 12 MICRO-CONTACTS, EXPLORATION LENGTH 34, Ø 0.8MM
DIXI MEDICAL
MICRODEEP MICRO-MACRO ELECTRODE
In Commercial Distribution

  • 03664539003412 ()

  • Macro Contact Length 2 Millimeters Macro Contact Spacing 2 Millimeters Micro Contact Exposure Diameter 0,02 Millimeters
MM08-06B33D12

  • Depth electrode
COAGULATION ELECTRODE FOR SCALP, ACCESSORY OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
COAGULATION ELECTRODE AND STOP
In Commercial Distribution

  • 03664539002927 ()
KIP-ACS-605

  • Depth electrode
COAGULATION ELECTRODE FOR DURA, ACCESSORY OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
COAGULATION ELECTRODE AND STOP
In Commercial Distribution

  • 03664539002910 ()
KIP-ACS-600

  • Depth electrode
TWIST DRILL FOR ANCHOR BOLT, HEXAGONAL SHANK, LENGTH 160MM, ACCESSORY OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
DRILL AND STOP
Not in Commercial Distribution

  • 03664539002811 ()
KIP-ACS-519

  • Depth electrode
TWIST DRILL FOR ANCHOR BOLT, HEXAGONAL SHANK, LENGTH 190MM, ACCESSORY OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
DRILL AND STOP
Not in Commercial Distribution

  • 03664539002804 ()
KIP-ACS-518

  • Depth electrode
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