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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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Origin 125º Short Neck Hip Stem - 09348215024062

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1325
In Commercial Distribution

  • 09348215024062 ()


  • Coated femoral stem prosthesis, modular

Origin 125º Short Neck Hip Stem - 09348215024055

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1225
In Commercial Distribution

  • 09348215024055 ()


  • Coated femoral stem prosthesis, modular

Origin 125º Short Neck Hip Stem - 09348215024048

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1125
In Commercial Distribution

  • 09348215024048 ()


  • Coated femoral stem prosthesis, modular

Origin 125º Short Neck Hip Stem - 09348215024031

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1025
In Commercial Distribution

  • 09348215024031 ()


  • Coated femoral stem prosthesis, modular

Origin 125º Short Neck Hip Stem - 09348215024024

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-0925
In Commercial Distribution

  • 09348215024024 ()


  • Coated femoral stem prosthesis, modular

Origin Short Neck Collared Hip Stem - 09348215024017

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1806
In Commercial Distribution

  • 09348215024017 ()


  • Coated femoral stem prosthesis, modular

Origin Short Neck Collared Hip Stem - 09348215024000

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1606
In Commercial Distribution

  • 09348215024000 ()


  • Coated femoral stem prosthesis, modular

Origin Short Neck Collared Hip Stem - 09348215023997

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1506
In Commercial Distribution

  • 09348215023997 ()


  • Coated femoral stem prosthesis, modular

Origin Short Neck Collared Hip Stem - 09348215023980

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1406
In Commercial Distribution

  • 09348215023980 ()


  • Coated femoral stem prosthesis, modular

Origin Short Neck Collared Hip Stem - 09348215023973

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1306
In Commercial Distribution

  • 09348215023973 ()


  • Coated femoral stem prosthesis, modular

Origin Short Neck Collared Hip Stem - 09348215023966

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1206
In Commercial Distribution

  • 09348215023966 ()


  • Coated femoral stem prosthesis, modular

Origin Short Neck Collared Hip Stem - 09348215023959

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1106
In Commercial Distribution

  • 09348215023959 ()


  • Coated femoral stem prosthesis, modular

Origin Short Neck Collared Hip Stem - 09348215023942

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1006
In Commercial Distribution

  • 09348215023942 ()


  • Coated femoral stem prosthesis, modular

Origin Short Neck Collared Hip Stem - 09348215023935

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-0906
In Commercial Distribution

  • 09348215023935 ()


  • Coated femoral stem prosthesis, modular

Origin Lateral Offset Collared Hip Stem - 09348215023836

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-0803
In Commercial Distribution

  • 09348215023836 ()


  • Coated femoral stem prosthesis, modular

Origin Lateral Offset Collared Hip Stem - 09348215017835

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1803
In Commercial Distribution

  • 09348215017835 ()


  • Coated femoral stem prosthesis, modular

Origin Lateral Offset Collared Hip Stem - 09348215017828

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1603
In Commercial Distribution

  • 09348215017828 ()


  • Coated femoral stem prosthesis, modular

Origin Lateral Offset Collared Hip Stem - 09348215017811

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1503
In Commercial Distribution

  • 09348215017811 ()


  • Coated femoral stem prosthesis, modular

Origin Lateral Offset Collared Hip Stem - 09348215017804

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1403
In Commercial Distribution

  • 09348215017804 ()


  • Coated femoral stem prosthesis, modular

Origin Lateral Offset Collared Hip Stem - 09348215017798

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1303
In Commercial Distribution

  • 09348215017798 ()


  • Coated femoral stem prosthesis, modular

Origin Lateral Offset Collared Hip Stem - 09348215017781

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1203
In Commercial Distribution

  • 09348215017781 ()


  • Coated femoral stem prosthesis, modular

Origin Lateral Offset Collared Hip Stem - 09348215017774

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1103
In Commercial Distribution

  • 09348215017774 ()


  • Coated femoral stem prosthesis, modular

Origin Lateral Offset Collared Hip Stem - 09348215017767

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1003
In Commercial Distribution

  • 09348215017767 ()


  • Coated femoral stem prosthesis, modular

Origin Lateral Offset Collared Hip Stem - 09348215017750

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-0903
In Commercial Distribution

  • 09348215017750 ()


  • Coated femoral stem prosthesis, modular

Origin 125° Short Neck Hip Stem - 09348215083557

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-0825
In Commercial Distribution

  • 09348215083557 ()


  • Coated femoral stem prosthesis, modular

Origin Short Neck Collared Hip Stem - 09348215083540

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-0806
In Commercial Distribution

  • 09348215083540 ()


  • Coated femoral stem prosthesis, modular

microTargeting™ Electrode and Insertion Tube Kit - 10873263001346

microTargeting STar Array Electrode and Insertion Tube Kit, 5x, for use with Stereotactic Frame and STar Drive. Contains: IT(AR16): Insertion Tube. IT(AR17): Insertion Tube w/ Stylet. MTDWLN(AR)(AR2): microTargeting Electrode. 66-CN-ET: Insertion Tube Extractor. Individual Specifications: IT(AR16) - 135mm tube length, 1.981mm OD, 0.96mm ID. IT(AR17) - 243.5mm tube length, 0.902mm OD, 0.597mm ID, 264mm stylet length (includes collar). MTDWLN(AR)(AR2) - 276.5mm electrode length, 10mm differential, 261.5mm protective tube length, 0.55mm OD. DZAP(L) 1 Meg
FHC, INC.
KTF1002-00134
Not in Commercial Distribution

  • 10873263001346 ()
  • 00873263001349 ()
KTF1002

  • Intracerebral cannula, implantable
  • Depth electrode

microTargeting™ Electrode and Insertion Tube Kit - 10873263001322

Array Insertion Electrode/Tube with Stylet Kit, 5x, Sterile, for use with Nexframe and microTargeting Drive. Contains: IT(AR8): Insertion Tube w/ Stylet. MTDPBN(PA)(DB2): microTargeting Electrode. Individual Specifications: IT(AR8) - 217mm tube length, 0.89mm OD, 0.58mm ID MTDPBN(PA)(DB2) - 249.2mm electrode length, 10mm differential length, 234.2mm protective tube length. 1 Meg RZAP, 0.56mm od
FHC, INC.
FC7100-00132
Not in Commercial Distribution

  • 10873263001322 ()
  • 00873263001325 ()
FC7100

  • Intracerebral cannula, implantable
  • Depth electrode

microTargeting™ Electrode and Insertion Tube Kit - 10873263001162

microTargeting D.ZAP Electrode Kit, 5x, Sterile, Single, 1 Meg, for use with NexFrame and NexDrive or mT Drive. Each box contains: 2x MTDPLN(PA)(DB2) D.ZAP Differential Electrode. 1x IT(DB3) Insertion tube with Stylet. 1x PT(DB5) Protective Tube. Individual Specifications: MTDPLN(PA)(DB2) - 249.2mm electrode length, 10mm tip exposure, 234.2mm protective tube length, .56mm od, 1.0 meg DZAP(L) IT(DB3) - 194mm length, 1.8mm od, 1.6mm id, PT(DB5) - 194mm length, 1.47mm od, 0.99mm id
FHC, INC.
FC4001-00116
Not in Commercial Distribution

  • 10873263001162 ()
  • 00873263001165 ()
FC4001

  • Depth electrode
  • Intracerebral cannula, implantable

microTargeting™ Electrode and Insertion Tube - 10873263001155

microTargeting single electrode insertion tubes and electrodes kit, 5x, Sterile for use with NexFrame and NexDrive or mT Drive. Each Box Contains: 2x MTDPBN(PA)(DB2) Electrode. 1x IT(DB3) Insertion Tube with Stylet. 1x PT(DB5) Spacer Tube. Individual Specifications: MTDPBN(PA)(DB2) - 249.2mm electrode length, 10mm tip expsure, 234.3mm protective tube length, 0.56mm od, 1.0 meg. RZAP IT(DB3) - 194mm length, 1.8mm od, 1.6mm id. PT(DB5) - 194mm length, 1.47mm od, 0.99mm id.
FHC, INC.
FC4000-00115
Not in Commercial Distribution

  • 10873263001155 ()
  • 00873263001158 ()
FC4000

  • Depth electrode
  • Intracerebral cannula, implantable

Gmate® Origin Blood Glucose Monitoring System - 08809301160206

No Description
PHILOSYS Co., Ltd
PG-310
In Commercial Distribution

  • 08809301160206 ()


  • Glucose monitoring system IVD, home-use

Gmate® Origin Blood Glucose Monitoring System - 08809301160145

No Description
PHILOSYS Co., Ltd
PG-310
In Commercial Distribution

  • 08809301160145 ()


  • Glucose monitoring system IVD, home-use

Gmate® Origin Blood Glucose Monitoring System - 08809301160077

No Description
PHILOSYS Co., Ltd
PG-310
In Commercial Distribution

  • 08809301160077 ()


  • Glucose monitoring system IVD, home-use

Origin 125º Short Neck Collared Hip Stem - 09348215024192

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1826
In Commercial Distribution

  • 09348215024192 ()


  • Coated femoral stem prosthesis, modular

Origin 125º Short Neck Collared Hip Stem - 09348215024185

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1626
In Commercial Distribution

  • 09348215024185 ()


  • Coated femoral stem prosthesis, modular

Origin 125º Short Neck Collared Hip Stem - 09348215024178

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1526
In Commercial Distribution

  • 09348215024178 ()


  • Coated femoral stem prosthesis, modular

Origin 125º Short Neck Collared Hip Stem - 09348215024161

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1426
In Commercial Distribution

  • 09348215024161 ()


  • Coated femoral stem prosthesis, modular

Origin 125º Short Neck Collared Hip Stem - 09348215024154

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1326
In Commercial Distribution

  • 09348215024154 ()


  • Coated femoral stem prosthesis, modular

Origin 125º Short Neck Collared Hip Stem - 09348215024147

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1226
In Commercial Distribution

  • 09348215024147 ()


  • Coated femoral stem prosthesis, modular

Origin 125º Short Neck Collared Hip Stem - 09348215024130

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1126
In Commercial Distribution

  • 09348215024130 ()


  • Coated femoral stem prosthesis, modular
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