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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 Short Neck Collared Hip Stem - 09348215083540

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

  • 09348215083540 ()


  • Coated femoral stem prosthesis, modular

Origin Data Management / Patient Data Manager - 04056481006662

No Description
Brainlab AG
2.3
Not in Commercial Distribution

  • 04056481006662 ()
25100-12

  • Radiology picture archiving and communication system workstation

Origin Data Management / Patient Data Manager - 04056481132453

No Description
Brainlab AG
2.3.1
Not in Commercial Distribution

  • 04056481132453 ()
25100-12A

  • Radiology picture archiving and communication system workstation

ACUSON Origin ICE Diagnostic Ultrasound System - 04068151012477

No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
11669400
In Commercial Distribution

  • 04068151012477 ()


  • General-purpose ultrasound imaging system

Origin 125º Short Neck Hip Stem - 09348215024109

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1825
In Commercial Distribution

  • 09348215024109 ()


  • Coated femoral stem prosthesis, modular

Origin 125º Short Neck Hip Stem - 09348215024093

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1625
In Commercial Distribution

  • 09348215024093 ()


  • Coated femoral stem prosthesis, modular

Origin 125º Short Neck Hip Stem - 09348215024086

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1525
In Commercial Distribution

  • 09348215024086 ()


  • Coated femoral stem prosthesis, modular

Origin 125º Short Neck Hip Stem - 09348215024079

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1425
In Commercial Distribution

  • 09348215024079 ()


  • Coated femoral stem prosthesis, modular

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

easypod - 04054839025860

easypod is an electromechanical auto-injector which automatically administers a pre-set dose of Saizen (somatropin [rDNA origin]) in cartridges.
EMD Serono, Inc.
U1222102
Not in Commercial Distribution

  • 04054839025860 ()


  • Empty self-injector, electronic

one.click - 04054839025792

one.click is a mechanical auto-injector which automatically administers a pre-set dose of Saizen (somatropin [rNDA origin]) in cartridges.
EMD Serono, Inc.
U1222402
Not in Commercial Distribution

  • 04054839025792 ()


  • Empty self-injector, mechanical

MSI Precision Specialty Instruments - 00194613069759

Iris Scissors Curved Overall Length 4 1/4" (110mm) With Precision Two Tone Finish Country Of Origin Germany
Med Saver, Inc.
19-13106
In Commercial Distribution

  • 00194613069759 ()


  • Intraocular scissors, conventional-hinge, reusable

MSI Precision Specialty Instruments - 00194613069711

Iris Scissors Straight Overall Length 4 1/4" (110mm) With Precision Two Tone Finish Country Of Origin Germany
Med Saver, Inc.
19-13105
In Commercial Distribution

  • 00194613069711 ()


  • Intraocular scissors, conventional-hinge, reusable

MSI Precision Specialty Instruments - 00194613069773

Iris Scissors Curved Right Overall Length Of 4 1/2" (115mm) With Precision Two Tone Finish Country Of Origin Germany
Med Saver, Inc.
19-13112
In Commercial Distribution

  • 00194613069773 ()


  • Intraocular scissors, conventional-hinge, reusable

MSI Precision Specialty Instruments - 00194613058982

Jorgenson Scissor With Strongly Curved Blades Overall Length Of 9" (230mm) With Precision Two Tone Finsh Country Of Origin Germany
Med Saver, Inc.
19-131010
In Commercial Distribution

  • 00194613058982 ()


  • General-purpose surgical scissors, reusable

MSI Precision Specialty Instruments - 00194613023416

Plastic Stitch Scissor Straight With Flat Round Shanks Overall Length 5" (125mm) Sharp / Blunt Beveled Blades Country Of Origin Germany
Med Saver, Inc.
19-13144
In Commercial Distribution

  • 00194613023416 ()


  • General-purpose surgical scissors, reusable

OneRF Ablation System - 00856895008658

80mm x 16 Contact sEEG - RF Probe
NEUROONE MEDICAL TECHNOLOGIES CORPORATION
NSEEG8016-RF
In Commercial Distribution

  • 00856895008658 ()


  • Percutaneous radio-frequency ablation probe, brain-ablation
  • Depth electrode

OneRF Ablation System - 00856895008641

68.5mm x 16 Contact sEEG - RF Probe
NEUROONE MEDICAL TECHNOLOGIES CORPORATION
NSEEG6916-RF
In Commercial Distribution

  • 00856895008641 ()


  • Percutaneous radio-frequency ablation probe, brain-ablation
  • Depth electrode

OneRF Ablation System - 00856895008634

61.5mm x 16 Contact sEEG - RF Probe
NEUROONE MEDICAL TECHNOLOGIES CORPORATION
NSEEG6216-RF
In Commercial Distribution

  • 00856895008634 ()


  • Percutaneous radio-frequency ablation probe, brain-ablation
  • Depth electrode

EVO sEEG Electrode - 00856895008627

54.5mm x 16 contact sEEG - RF Probe
NEUROONE MEDICAL TECHNOLOGIES CORPORATION
NSEEG5516-RF
In Commercial Distribution

  • 00856895008627 ()


  • Depth electrode
  • Percutaneous radio-frequency ablation probe, brain-ablation

EVO sEEG Electrode - 00856895008610

47.5mm x 14 Contact sEEG - RF Probe
NEUROONE MEDICAL TECHNOLOGIES CORPORATION
NSEEG4814-RF
In Commercial Distribution

  • 00856895008610 ()


  • Depth electrode
  • Percutaneous radio-frequency ablation probe, brain-ablation

EVO sEEG Electrode - 00856895008603

40.5mm x 12 Contact sEEG - RF Probe
NEUROONE MEDICAL TECHNOLOGIES CORPORATION
NSEEG4112-RF
In Commercial Distribution

  • 00856895008603 ()


  • Depth electrode
  • Percutaneous radio-frequency ablation probe, brain-ablation

EVO sEEG Electrode - 00856895008597

33.5mm x 10 Contact sEEG - RF Probe
NEUROONE MEDICAL TECHNOLOGIES CORPORATION
NSEEG3410-RF
In Commercial Distribution

  • 00856895008597 ()


  • Depth electrode
  • Percutaneous radio-frequency ablation probe, brain-ablation

EVO sEEG Electrode - 00856895008580

26.5mm x 8 Contact sEEG - RF Probe
NEUROONE MEDICAL TECHNOLOGIES CORPORATION
NSEEG2708-RF
In Commercial Distribution

  • 00856895008580 ()


  • Percutaneous radio-frequency ablation probe, brain-ablation
  • Depth electrode

EVO sEEG Electrode - 00856895008573

16mm x 5 Contact sEEG Electrode - RF Probe
NEUROONE MEDICAL TECHNOLOGIES CORPORATION
NSEEG1605-RF
In Commercial Distribution

  • 00856895008573 ()


  • Depth electrode
  • Percutaneous radio-frequency ablation probe, brain-ablation

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
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