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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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Monarch™ Cart Software v4.1.0 - 10810068810599

Monarch™ Cart Software v4.1.0
AURIS HEALTH, INC.
Version 4.1.0
In Commercial Distribution

  • 10810068810599 ()


  • Robotic surgical system application software

Monarch™ Tower Software v4.1.0 - 10810068810582

Monarch™ Tower Software v4.1.0
AURIS HEALTH, INC.
Version 4.1.0
In Commercial Distribution

  • 10810068810582 ()


  • Robotic surgical system application software

Monarch™ Laptop P17/P73 Linux USB Image v2.2.4 - 10810068810506

Monarch™ Laptop P17/P73 Linux USB Image v2.2.4
AURIS HEALTH, INC.
Version 2.2.4
In Commercial Distribution

  • 10810068810506 ()


  • Robotic surgical system application software

Monarch™ Laptop P70 Linux USB Image v2.2.4 - 10810068810490

Monarch™ Laptop P70 Linux USB Image v2.2.4
AURIS HEALTH, INC.
Version 2.2.4
In Commercial Distribution

  • 10810068810490 ()


  • Robotic surgical system application software

Monarch™ Software Cart v2.2.4 - 10810068810483

Monarch™ Software Cart v2.2.4
AURIS HEALTH, INC.
Version 2.2.4
In Commercial Distribution

  • 10810068810483 ()


  • Robotic surgical system application software

Monarch™ Software Tower v2.2.4 - 10810068810476

Monarch™ Software Tower v2.2.4
AURIS HEALTH, INC.
Version 2.2.4
In Commercial Distribution

  • 10810068810476 ()


  • Robotic surgical system application software

VISICOIL - B887VC110030PL0

1.10mm x 3.0cm VISICOIL loaded in an 17 gauge brachytherapy needle.
Izi Medical Products, LLC
VC-110-030-PL
In Commercial Distribution

  • B887VC110030PL0 ()
VC-110-030-PL

  • Radiological image marker, implantable

VISICOIL - B887VC110020PL300

1.10mm x 2.0cm VISICOIL loaded in an 17 gauge pre-waxed brachytherapy needle.
Izi Medical Products, LLC
VC-110-020-PL30
In Commercial Distribution

  • B887VC110020PL300 ()
VC-110-020-PL30

  • Radiological image marker, implantable

VISICOIL - B887VC110020PL0

1.10mm x 2.0cm VISICOIL loaded in an 17 gauge pre-waxed brachytherapy needle.
Izi Medical Products, LLC
VC-110-020-PL
In Commercial Distribution

  • B887VC110020PL0 ()
VC-110-020-PL

  • Radiological image marker, implantable

VISICOIL - B887VC110010PL300

1.10mm x 1.0cm VISICOIL loaded in an 17 gauge pre-waxed brachytherapy needle.
Izi Medical Products, LLC
VC-110-010-PL30
In Commercial Distribution

  • B887VC110010PL300 ()
VC-110-010-PL30

  • Radiological image marker, implantable

VISICOIL - B887VC110010PL0

1.10mm x 1.0cm VISICOIL loaded in an 17 gauge pre-waxed brachytherapy needle.
Izi Medical Products, LLC
VC-110-010-PL
In Commercial Distribution

  • B887VC110010PL0 ()
VC-110-010-PL

  • Radiological image marker, implantable

VISICOIL - B887VC110005PL0

1.10mm x 0.5cm VISICOIL loaded in an 17 gauge pre-waxed brachytherapy needle.
Izi Medical Products, LLC
VC-110-005-PL
In Commercial Distribution

  • B887VC110005PL0 ()
VC-110-005-PL

  • Radiological image marker, implantable

VISICOIL - B887VC075030PL0

0.75mm x 3.0cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle.
Izi Medical Products, LLC
VC-075-030-PL
In Commercial Distribution

  • B887VC075030PL0 ()
VC-075-030-PL

  • Radiological image marker, implantable

VISICOIL - B887VC075020PL300

0.75mm x 2.0cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle.
Izi Medical Products, LLC
VC-075-020-PL30
In Commercial Distribution

  • B887VC075020PL300 ()
VC-075-020-PL30

  • Radiological image marker, implantable

VISICOIL - B887VC075020PL120

0.75mm x 2.0cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle.
Izi Medical Products, LLC
VC-075-020-PL12
In Commercial Distribution

  • B887VC075020PL120 ()
VC-075-020-PL12

  • Radiological image marker, implantable

VISICOIL - B887VC075020PL0

0.75mm x 2.0cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle.
Izi Medical Products, LLC
VC-075-020-PL
In Commercial Distribution

  • B887VC075020PL0 ()
VC-075-020-PL

  • Radiological image marker, implantable

VISICOIL - B887VC075010PL300

0.75mm x 1.0cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle.
Izi Medical Products, LLC
VC-075-010-PL30
In Commercial Distribution

  • B887VC075010PL300 ()
VC-075-010-PL30

  • Radiological image marker, implantable

VISICOIL - B887VC075010PL120

0.75mm x 1.0cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle.
Izi Medical Products, LLC
VC-075-010-PL12
In Commercial Distribution

  • B887VC075010PL120 ()
VC-075-010-PL12

  • Radiological image marker, implantable

VISICOIL - B887VC075010PL0

0.75mm x 1.0cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle.
Izi Medical Products, LLC
VC-075-010-PL
In Commercial Distribution

  • B887VC075010PL0 ()
VC-075-010-PL

  • Radiological image marker, implantable

VISICOIL - B887VC075005PL300

0.75mm x 0.5cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle.
Izi Medical Products, LLC
VC-075-005-PL30
In Commercial Distribution

  • B887VC075005PL300 ()
VC-075-005-PL30

  • Radiological image marker, implantable

VISICOIL - B887VC075005PL120

0.75mm x 0.5cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle.
Izi Medical Products, LLC
VC-075-005-PL12
In Commercial Distribution

  • B887VC075005PL120 ()
VC-075-005-PL12

  • Radiological image marker, implantable

VISICOIL - B887VC075005PL0

0.75mm x 0.50cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle.
Izi Medical Products, LLC
VC-075-005-PL
In Commercial Distribution

  • B887VC075005PL0 ()
VC-075-005-PL

  • Radiological image marker, implantable

VISICOIL - B887VC050020PLSL0

0.50mm x 2.0cm VISICOIL loaded in an 19 gauge pre-waxed brachytherapy needle.
Izi Medical Products, LLC
VC-050-020-PLSL
In Commercial Distribution

  • B887VC050020PLSL0 ()
VC-050-020-PLSL

  • Radiological image marker, implantable

VISICOIL - B887VC050020PL0

0.5mm x 2.0cm VISICOIL loaded in a 18 gauge pre-waxed brachytherapy needle.
Izi Medical Products, LLC
VC-050-020-PL
In Commercial Distribution

  • B887VC050020PL0 ()
VC-050-020-PL

  • Radiological image marker, implantable

VISICOIL - B887VC050010PLSL0

0.5mm x 1.0cm VISICOIL loaded in an 19 gauge pre-waxed brachytherapy needle.
Izi Medical Products, LLC
VC-050-010-PLSL
In Commercial Distribution

  • B887VC050010PLSL0 ()
VC-050-010-PLSL

  • Radiological image marker, implantable

VISICOIL - B887VC050010PL300

0.5mm x 1.0cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle.
Izi Medical Products, LLC
VC-050-010-PL30
In Commercial Distribution

  • B887VC050010PL300 ()
VC-050-010-PL30

  • Radiological image marker, implantable

VISICOIL - B887VC050010PL0

0.50mm x 1.0cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle.
Izi Medical Products, LLC
VC-050-010-PL
In Commercial Distribution

  • B887VC050010PL0 ()
VC-050-010-PL

  • Radiological image marker, implantable

VISICOIL - B887VC050005PLSL0

0.50mm x 0.5cm VISICOIL loaded in an 19 gauge pre-waxed brachytherapy needle.
Izi Medical Products, LLC
VC-050-005-PLSL
In Commercial Distribution

  • B887VC050005PLSL0 ()
VC-050-005-PLSL

  • Radiological image marker, implantable

VISICOIL - B887VC050005PL300

0.50mm x 0.5cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle.
Izi Medical Products, LLC
VC-050-005-PL30
In Commercial Distribution

  • B887VC050005PL300 ()
VC-050-005-PL30

  • Radiological image marker, implantable

VISICOIL - B887VC050005PL0

0.50mm x 0.5cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle.
Izi Medical Products, LLC
VC-050-005-PL
In Commercial Distribution

  • B887VC050005PL0 ()
VC-050-005-PL

  • Radiological image marker, implantable

VISICOIL - B887VC035040PL0

0.35mm x 4.0cm VISICOIL loaded in an 19 gauge pre-waxed brachytherapy needle.
Izi Medical Products, LLC
VC-035-040-PL
In Commercial Distribution

  • B887VC035040PL0 ()
VC-035-040-PL

  • Radiological image marker, implantable

VISICOIL - B887VC035030PL0

0.35mm x 3.0cm VISICOIL loaded in an 19 gauge pre-waxed brachytherapy needle.
Izi Medical Products, LLC
VC-035-030-PL
In Commercial Distribution

  • B887VC035030PL0 ()
VC-035-030-PL

  • Radiological image marker, implantable

VISICOIL - B887VC035020PL0

0.35mm x 2.0cm VISICOIL loaded in an 19 gauge pre-waxed brachytherapy needle.
Izi Medical Products, LLC
VC-035-020-PL
In Commercial Distribution

  • B887VC035020PL0 ()
VC-035-020-PL

  • Radiological image marker, implantable

VISICOIL - B887VC035010PL0

0.35mm x 1.0cm VISICOIL loaded in an 19 gauge pre-waxed brachytherapy needle.
Izi Medical Products, LLC
VC-035-010-PL
In Commercial Distribution

  • B887VC035010PL0 ()
VC-035-010-PL

  • Radiological image marker, implantable

VISICOIL - B887VC035005PL0

0.35mm x 0.5cm VISICOIL loaded in an 19 gauge pre-waxed brachytherapy needle.
Izi Medical Products, LLC
VC-035-005-PL
In Commercial Distribution

  • B887VC035005PL0 ()
VC-035-005-PL

  • Radiological image marker, implantable

VISICOIL - B887SN050010PL080

0.50mm x 1.0cm VISICOIL loaded in an 21 gauge pre-waxed brachytherapy needle.
Izi Medical Products, LLC
SN-050-010-PL08
In Commercial Distribution

  • B887SN050010PL080 ()
SN-050-010-PL08

  • Radiological image marker, implantable

VISICOIL - B887SN050005PL200

0.5mm x 0.5cm Gold Fiducial Marker Pre-Loaded Needle 21g x 20cm
Izi Medical Products, LLC
SN-050-005-PL20
In Commercial Distribution

  • B887SN050005PL200 ()
SN-050-005-PL20

  • Radiological image marker, implantable

VISICOIL - B887SN035020PL080

0.35mm x 2.0cm VISICOIL loaded in an 22 gauge pre-waxed brachytherapy needle.
Izi Medical Products, LLC
SN-035-020-PL08
In Commercial Distribution

  • B887SN035020PL080 ()
SN-035-020-PL08

  • Radiological image marker, implantable

VISICOIL MR - B887SHZ035020220

0.35mm x 2cm VISICOIL MR Platinum loaded into a pre-waxed 22 gauge 38.5cm needle.
Izi Medical Products, LLC
SHZ-035-020-22
In Commercial Distribution

  • B887SHZ035020220 ()
SHZ-035-020-22

  • Radiological image marker, implantable

VISICOIL MR - B887SHZ035010220

0.35mm x 1.0cm VISICOIL MR Platinum loaded into a pre-waxed 22 gauge 38.5cm needle.
Izi Medical Products, LLC
SHZ-035-010-22
In Commercial Distribution

  • B887SHZ035010220 ()
SHZ-035-010-22

  • Radiological image marker, implantable

VISICOIL MR - B887SHZ035005220

0.35mm x 0.5cm VISICOIL MR Platinum loaded into a pre-waxed 22 gauge 38.5cm needle.
Izi Medical Products, LLC
SHZ-035-005-22
In Commercial Distribution

  • B887SHZ035005220 ()
SHZ-035-005-22

  • Radiological image marker, implantable

Gold Fiducial - B887GF18230

3 Pack 1.0mm x 5mm Gold Fiducial Marker Pre-Loaded in a 18g x 20cm Needle.
Izi Medical Products, LLC
GF1823
In Commercial Distribution

  • B887GF18230 ()
GF1823

  • Radiological image marker, implantable

Gold Fiducial - B887GF15330

3 Pack 1.2mm x 5mm Gold Fiducial Marker Pre-Loaded in a 17g x 30cm Needle.
Izi Medical Products, LLC
GF1533
In Commercial Distribution

  • B887GF15330 ()
GF1533

  • Radiological image marker, implantable

Gold Fiducial - B887GF15240

4 Pack 1.2mm x 5mm Gold Fiducial Marker Pre-Loaded in a 17g x 20cm Needle.
Izi Medical Products, LLC
GF1524
In Commercial Distribution

  • B887GF15240 ()
GF1524

  • Radiological image marker, implantable

Gold Fiducial - B887GF15230

3 Pack 1.2mm x 5mm Gold Fiducial Marker Pre-Loaded in a 17g x 20cm Needle.
Izi Medical Products, LLC
GF1523
In Commercial Distribution

  • B887GF15230 ()
GF1523

  • Radiological image marker, implantable

Gold Fiducial - B887GF15210

1.2mm x 5mm Gold Fiducial Marker Pre-Loaded in a 17g x 20cm Needle.
Izi Medical Products, LLC
GF1521
In Commercial Distribution

  • B887GF15210 ()
GF1521

  • Radiological image marker, implantable

Gold Fiducial - B887GF15033

3 Pack - 1.0mm x 5mm Gold Fiducial Marker Loose
Izi Medical Products, LLC
GF1503
In Commercial Distribution

  • B887GF1501 ()
  • B887GF15033 ()
GF1503

  • Radiological image marker, implantable

Gold Fiducial - B887GF15030

3 Pack - 1.0mm x 5mm Gold Fiducial Marker Loose
Izi Medical Products, LLC
GF1503
In Commercial Distribution

  • B887GF15030 ()
GF1503

  • Radiological image marker, implantable

Gold Fiducial - B887GF15010

1.0mm x 5mm Gold Fiducial Marker Loose
Izi Medical Products, LLC
GF1501
In Commercial Distribution

  • B887GF15010 ()
GF1501

  • Radiological image marker, implantable

Gold Fiducial - B887GF13340

4 Pack 1.2mm x 3mm Gold Fiducial Marker Pre-Loaded in a 17g x 30cm Needle.
Izi Medical Products, LLC
GF1334
In Commercial Distribution

  • B887GF13340 ()
GF1334

  • Radiological image marker, implantable
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