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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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72" GAIT BELT NATURAL METAL BUCKLE - 50610570149945

No Description
Bird & Cronin, LLC
08146545
In Commercial Distribution

  • 50610570149945 ()
  • 00610570149940 ()


  • Gait rehabilitation system harness

72" WALKING BELT PASTEL STRIPE - 50610570004046

No Description
Bird & Cronin, LLC
08140780
In Commercial Distribution

  • 50610570004046 ()
  • 00610570004041 ()


  • Gait rehabilitation system harness

60" WALKING BELT PASTEL STRIPE - 50610570003612

No Description
Bird & Cronin, LLC
08140680
In Commercial Distribution

  • 50610570003612 ()
  • 00610570003617 ()


  • Gait rehabilitation system harness

Integra® - 10381780034766

The Integra Sphenoidal Electrode is designed for investigative intraoperative monitoring of cortical electrical activity specifically at the undersurface of the temporal lobe. It has one platinum contact and is supplied with an insertion needle.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
40M08
Not in Commercial Distribution

  • M27240M081 ()
  • 10381780034766 ()

  • Insertion needle 64mm Length


  • Depth electrode

Integra® - 10381780037088

The Integra Sphenoidal Electrode is designed for investigative intraoperative monitoring of cortical electrical activity specifically at the undersurface of the temporal lobe. It has one platinum contact and is supplied with an insertion needle.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
EDSEP
Not in Commercial Distribution

  • M272EDSEP1 ()
  • 10381780037088 ()


  • Depth electrode

Auragen™ - 10381780036531

The Auragen™ depth electrodes are designed for intraoperative monitoring of cortical electrical activity in order to define the location of epileptogenic foci. They are inserted stereotaxically into the brain. Depth electrodes are available with 4 to 12 platinum/iridium contacts. The type of depth electrode used is dependent on the procedure and the size of area being tested.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
AU8D5L25
Not in Commercial Distribution

  • M272AU8D5L251 ()
  • 10381780036531 ()

  • 8 platinum contacts


  • Depth electrode

Auragen™ - 10381780036524

The Auragen™ depth electrodes are designed for intraoperative monitoring of cortical electrical activity in order to define the location of epileptogenic foci. They are inserted stereotaxically into the brain. Depth electrodes are available with 4 to 12 platinum/iridium contacts. The type of depth electrode used is dependent on the procedure and the size of area being tested.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
AU8D10L5
Not in Commercial Distribution

  • M272AU8D10L51 ()
  • 10381780036524 ()

  • 8 platinum contacts


  • Depth electrode

Auragen™ - 10381780036517

The Auragen™ depth electrodes are designed for intraoperative monitoring of cortical electrical activity in order to define the location of epileptogenic foci. They are inserted stereotaxically into the brain. Depth electrodes are available with 4 to 12 platinum/iridium contacts. The type of depth electrode used is dependent on the procedure and the size of area being tested.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
AU8D10L25
Not in Commercial Distribution

  • M272AU8D10L251 ()
  • 10381780036517 ()

  • 8 platinum contacts


  • Depth electrode

Auragen™ - 10381780036456

The Auragen™ depth electrodes are designed for intraoperative monitoring of cortical electrical activity in order to define the location of epileptogenic foci. They are inserted stereotaxically into the brain. Depth electrodes are available with 4 to 12 platinum/iridium contacts. The type of depth electrode used is dependent on the procedure and the size of area being tested.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
AU6D5L25
Not in Commercial Distribution

  • M272AU6D5L251 ()
  • 10381780036456 ()

  • 6 platinum contacts


  • Depth electrode

Auragen™ - 10381780036449

The Auragen™ depth electrodes are designed for intraoperative monitoring of cortical electrical activity in order to define the location of epileptogenic foci. They are inserted stereotaxically into the brain. Depth electrodes are available with 4 to 12 platinum/iridium contacts. The type of depth electrode used is dependent on the procedure and the size of area being tested.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
AU6D10L5
Not in Commercial Distribution

  • M272AU6D10L51 ()
  • 10381780036449 ()

  • 6 platinum contacts


  • Depth electrode

Auragen™ - 10381780036432

The Auragen™ depth electrodes are designed for intraoperative monitoring of cortical electrical activity in order to define the location of epileptogenic foci. They are inserted stereotaxically into the brain. Depth electrodes are available with 4 to 12 platinum/iridium contacts. The type of depth electrode used is dependent on the procedure and the size of area being tested.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
AU6D10L25
Not in Commercial Distribution

  • M272AU6D10L251 ()
  • 10381780036432 ()

  • 6 platinum contacts


  • Depth electrode

Auragen™ - 10381780036326

The Auragen™ depth electrodes are designed for intraoperative monitoring of cortical electrical activity in order to define the location of epileptogenic foci. They are inserted stereotaxically into the brain. Depth electrodes are available with 4 to 12 platinum/iridium contacts. The type of depth electrode used is dependent on the procedure and the size of area being tested.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
AU4D5L25
Not in Commercial Distribution

  • M272AU4D5L251 ()
  • 10381780036326 ()

  • 4 platinum contacts


  • Depth electrode

Auragen™ - 10381780036319

The Auragen™ depth electrodes are designed for intraoperative monitoring of cortical electrical activity in order to define the location of epileptogenic foci. They are inserted stereotaxically into the brain. Depth electrodes are available with 4 to 12 platinum/iridium contacts. The type of depth electrode used is dependent on the procedure and the size of area being tested.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
AU4D10L5
Not in Commercial Distribution

  • M272AU4D10L51 ()
  • 10381780036319 ()

  • 4 platinum contacts


  • Depth electrode

Auragen™ - 10381780036302

The Auragen™ depth electrodes are designed for intraoperative monitoring of cortical electrical activity in order to define the location of epileptogenic foci. They are inserted stereotaxically into the brain. Depth electrodes are available with 4 to 12 platinum/iridium contacts. The type of depth electrode used is dependent on the procedure and the size of area being tested.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
AU4D10L25
Not in Commercial Distribution

  • M272AU4D10L251 ()
  • 10381780036302 ()

  • 4 platinum contacts


  • Depth electrode

Auragen™ - 10381780036111

The Auragen™ depth electrodes are designed for intraoperative monitoring of cortical electrical activity in order to define the location of epileptogenic foci. They are inserted stereotaxically into the brain. Depth electrodes are available with 4 to 12 platinum/iridium contacts. The type of depth electrode used is dependent on the procedure and the size of area being tested.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
AU12D5L25
Not in Commercial Distribution

  • M272AU12D5L251 ()
  • 10381780036111 ()

  • 12 platinum contacts


  • Depth electrode

Auragen™ - 10381780036104

The Auragen™ depth electrodes are designed for intraoperative monitoring of cortical electrical activity in order to define the location of epileptogenic foci. They are inserted stereotaxically into the brain. Depth electrodes are available with 4 to 12 platinum/iridium contacts. The type of depth electrode used is dependent on the procedure and the size of area being tested.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
AU10D5L25
Not in Commercial Distribution

  • M272AU10D5L251 ()
  • 10381780036104 ()

  • 10 platinum contacts


  • Depth electrode

SYNCHROMED ® II - 00613994779229

PUMP 8637-20 SM2 20ML EMAN US JUN BATRY
MEDTRONIC, INC.
8637-20
Not in Commercial Distribution

  • 00613994779229 ()

  • Total Volume: 20.0 Milliliter


  • Implantable intrathecal infusion pump, programmable

Origin Stem Size 20 Template - 09348215055974

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-170
In Commercial Distribution

  • 09348215055974 ()


  • Surgical implant template, reusable

Origin Stem Size 18 Template - 09348215055967

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-168
In Commercial Distribution

  • 09348215055967 ()


  • Surgical implant template, reusable

Origin Stem Size 16 Template - 09348215055950

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-166
In Commercial Distribution

  • 09348215055950 ()


  • Surgical implant template, reusable

Origin Stem Size 15 Template - 09348215055943

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-165
In Commercial Distribution

  • 09348215055943 ()


  • Surgical implant template, reusable

Origin Stem Size 14 Template - 09348215055936

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-164
In Commercial Distribution

  • 09348215055936 ()


  • Surgical implant template, reusable

Origin Stem Size 13 Template - 09348215055929

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-163
In Commercial Distribution

  • 09348215055929 ()


  • Surgical implant template, reusable

Origin Stem Size 12 Template - 09348215055912

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-162
In Commercial Distribution

  • 09348215055912 ()


  • Surgical implant template, reusable

Origin Stem Size 11 Template - 09348215055905

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-161
In Commercial Distribution

  • 09348215055905 ()


  • Surgical implant template, reusable

Origin Stem Size 10 Template - 09348215055899

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-160
In Commercial Distribution

  • 09348215055899 ()


  • Surgical implant template, reusable

Origin Stem Size 9 Template - 09348215055882

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-159
In Commercial Distribution

  • 09348215055882 ()


  • Surgical implant template, reusable

Origin Stem Size 8 Template - 09348215055875

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-158
In Commercial Distribution

  • 09348215055875 ()


  • Surgical implant template, reusable

Origin DAA Trial Neck HO - 09348215055790

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-182-024
In Commercial Distribution

  • 09348215055790 ()


  • Surgical implant template, reusable

Origin DAA Trial Neck SO - 09348215055783

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-182-023
In Commercial Distribution

  • 09348215055783 ()


  • Surgical implant template, reusable

Origin Starter Broach (Chilly Pepper) - 09348215055356

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
101-139
In Commercial Distribution

  • 09348215055356 ()


  • Orthopaedic broach

Origin DAA Stem, Coxa Vara - 09348215092825

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1804
In Commercial Distribution

  • 09348215092825 ()


  • Coated femoral stem prosthesis, modular

Origin DAA Stem, Coxa Vara - 09348215092818

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1604
In Commercial Distribution

  • 09348215092818 ()


  • Coated femoral stem prosthesis, modular

Origin DAA Stem, Coxa Vara - 09348215092801

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1504
In Commercial Distribution

  • 09348215092801 ()


  • Coated femoral stem prosthesis, modular

Origin DAA Stem, Coxa Vara - 09348215092795

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1404
In Commercial Distribution

  • 09348215092795 ()


  • Coated femoral stem prosthesis, modular

Origin DAA Stem, Coxa Vara - 09348215092788

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1304
In Commercial Distribution

  • 09348215092788 ()


  • Coated femoral stem prosthesis, modular

Origin DAA Stem, Coxa Vara - 09348215092771

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1204
In Commercial Distribution

  • 09348215092771 ()


  • Coated femoral stem prosthesis, modular

Origin DAA Stem, Coxa Vara - 09348215092764

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1104
In Commercial Distribution

  • 09348215092764 ()


  • Coated femoral stem prosthesis, modular

Origin DAA Stem, Coxa Vara - 09348215092757

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1004
In Commercial Distribution

  • 09348215092757 ()


  • Coated femoral stem prosthesis, modular

Origin DAA Stem, Coxa Vara - 09348215092740

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-0904
In Commercial Distribution

  • 09348215092740 ()


  • Coated femoral stem prosthesis, modular

Origin Short 125deg Trial Neck - 09348215081423

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-182-027
In Commercial Distribution

  • 09348215081423 ()


  • Surgical implant template, reusable

Origin DAA Stem, High Offset - 09348215088569

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1813
In Commercial Distribution

  • 09348215088569 ()


  • Coated femoral stem prosthesis, modular

Origin DAA Stem, Standard Offset - 09348215088552

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1812
In Commercial Distribution

  • 09348215088552 ()


  • Coated femoral stem prosthesis, modular

Origin DAA Stem, High Offset - 09348215088545

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1613
In Commercial Distribution

  • 09348215088545 ()


  • Coated femoral stem prosthesis, modular

Origin DAA Stem, Standard Offset - 09348215088538

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1612
In Commercial Distribution

  • 09348215088538 ()


  • Coated femoral stem prosthesis, modular

Origin DAA Stem, High Offset - 09348215088521

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1513
In Commercial Distribution

  • 09348215088521 ()


  • Coated femoral stem prosthesis, modular

Origin DAA Stem, Standard Offset - 09348215088514

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1512
In Commercial Distribution

  • 09348215088514 ()


  • Coated femoral stem prosthesis, modular

Origin DAA Stem, High Offset - 09348215088507

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1413
In Commercial Distribution

  • 09348215088507 ()


  • Coated femoral stem prosthesis, modular

Origin DAA Stem, Standard Offset - 09348215088491

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1412
In Commercial Distribution

  • 09348215088491 ()


  • Coated femoral stem prosthesis, modular

Origin DAA Stem, High Offset - 09348215088484

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1313
In Commercial Distribution

  • 09348215088484 ()


  • Coated femoral stem prosthesis, modular
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