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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 Size 13 Template - 09348215074760

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-113
In Commercial Distribution

  • 09348215074760 ()


  • Surgical implant template, reusable

Origin Size 12 Template - 09348215074753

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

  • 09348215074753 ()


  • Surgical implant template, reusable

Origin Size 11 Template - 09348215074746

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-111
In Commercial Distribution

  • 09348215074746 ()


  • Surgical implant template, reusable

Origin Size 10 Template - 09348215074739

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-110
In Commercial Distribution

  • 09348215074739 ()


  • Surgical implant template, reusable

Origin NS Trial Neck - 09348215087449

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-23-5016
In Commercial Distribution

  • 09348215087449 ()


  • Surgical implant template, reusable

Origin NS Trial Neck - 09348215087425

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-23-5014
In Commercial Distribution

  • 09348215087425 ()


  • Surgical implant template, reusable

Origin NS Trial Neck - 09348215087418

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-23-5013
In Commercial Distribution

  • 09348215087418 ()


  • Surgical implant template, reusable

Origin NS Trial Neck - 09348215087432

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-23-5015
In Commercial Distribution

  • 09348215087432 ()


  • Surgical implant template, reusable

Origin NS Stem Broach - 09348215087333

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-23-6040
In Commercial Distribution

  • 09348215087333 ()


  • Orthopaedic broach

Origin NS Stem Broach - 09348215087319

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-23-6020
In Commercial Distribution

  • 09348215087319 ()


  • Orthopaedic broach

Origin NS Stem Broach - 09348215087340

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-23-6050
In Commercial Distribution

  • 09348215087340 ()


  • Orthopaedic broach

Origin NS Stem Broach - 09348215087326

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-23-6030
In Commercial Distribution

  • 09348215087326 ()


  • Orthopaedic broach

Origin NS Stem Broach - 09348215087302

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-23-6010
In Commercial Distribution

  • 09348215087302 ()


  • Orthopaedic broach

Origin NS Stem Broach - 09348215087296

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-23-6000
In Commercial Distribution

  • 09348215087296 ()


  • Orthopaedic broach

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 - 09348215080150

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-2006
In Commercial Distribution

  • 09348215080150 ()


  • Surgical implant template, reusable

Origin DAA Trial Neck - 09348215080143

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-2005
In Commercial Distribution

  • 09348215080143 ()


  • Surgical implant template, reusable

Origin DAA Trial Neck - 09348215080136

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-2004
In Commercial Distribution

  • 09348215080136 ()


  • Surgical implant template, reusable

Origin DAA Trial Neck - 09348215080129

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-2003
In Commercial Distribution

  • 09348215080129 ()


  • Surgical implant template, reusable

Origin DAA Trial Neck - 09348215080112

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-2002
In Commercial Distribution

  • 09348215080112 ()


  • Surgical implant template, reusable

Origin DAA Trial Neck - 09348215080105

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-2001
In Commercial Distribution

  • 09348215080105 ()


  • Surgical implant template, reusable

Origin DAA Broach - 09348215080433

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-3018
In Commercial Distribution

  • 09348215080433 ()


  • Orthopaedic broach

Origin DAA Broach - 09348215080426

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-3016
In Commercial Distribution

  • 09348215080426 ()


  • Orthopaedic broach

Origin DAA Broach - 09348215080419

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-3015
In Commercial Distribution

  • 09348215080419 ()


  • Orthopaedic broach

Origin DAA Broach - 09348215080402

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-3014
In Commercial Distribution

  • 09348215080402 ()


  • Orthopaedic broach

Origin DAA Broach - 09348215080396

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-3013
In Commercial Distribution

  • 09348215080396 ()


  • Orthopaedic broach

Origin DAA Broach - 09348215080389

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-3012
In Commercial Distribution

  • 09348215080389 ()


  • Orthopaedic broach

Origin DAA Broach - 09348215080372

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-3011
In Commercial Distribution

  • 09348215080372 ()


  • Orthopaedic broach

Origin DAA Broach - 09348215080365

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-3010
In Commercial Distribution

  • 09348215080365 ()


  • Orthopaedic broach

Origin DAA Broach - 09348215080358

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-3009
In Commercial Distribution

  • 09348215080358 ()


  • Orthopaedic broach

Origin DAA Broach - 09348215080341

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-3008
In Commercial Distribution

  • 09348215080341 ()


  • Orthopaedic broach

Origin Broach - 09348215039783

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1809
In Commercial Distribution

  • 09348215039783 ()


  • Orthopaedic broach

Origin Broach - 09348215039776

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1609
In Commercial Distribution

  • 09348215039776 ()


  • Orthopaedic broach

Origin Broach - 09348215039769

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1509
In Commercial Distribution

  • 09348215039769 ()


  • Orthopaedic broach

Origin Broach - 09348215039752

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1409
In Commercial Distribution

  • 09348215039752 ()


  • Orthopaedic broach

Origin Broach - 09348215039745

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1309
In Commercial Distribution

  • 09348215039745 ()


  • Orthopaedic broach

Origin Broach - 09348215039738

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1209
In Commercial Distribution

  • 09348215039738 ()


  • Orthopaedic broach

Origin Broach - 09348215039721

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1109
In Commercial Distribution

  • 09348215039721 ()


  • Orthopaedic broach

Origin Broach - 09348215039714

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1009
In Commercial Distribution

  • 09348215039714 ()


  • Orthopaedic broach

Origin Broach - 09348215039707

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-0909
In Commercial Distribution

  • 09348215039707 ()


  • Orthopaedic broach

Origin Broach - 09348215039691

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-0809
In Commercial Distribution

  • 09348215039691 ()


  • Orthopaedic broach

Origin Broach - 09348215039684

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-0609
In Commercial Distribution

  • 09348215039684 ()


  • Orthopaedic broach

Optimal-G - 07290017844312

The Optimal-G is a robotics-based powered exercise equipment intended to redevelop muscles and to restore motion to joints during the rehabilitation of a patient recovering from a stroke or other neuromuscular condition. The Optimal-G enables passive and allows active motions of the lower limbs, which are carried out by a single robotic guide. The robotic guide is modular, and designed to be appropriate for use both in the in-patient and outpatient facilities. It incorporates sensors for accurate motion control of the robotic guide and provides measures of patient performance.
MOTORIKA MEDICAL (ISRAEL) LTD
A
In Commercial Distribution

  • 07290017844312 ()
OG01-0000-01

  • Gait rehabilitation system harness

Omnia Medical PsiF - 00843511100636

PsiF Post Packer (Long Impactor) Instrument
OMNIA MEDICAL, LLC
01-01-0010
In Commercial Distribution

  • 00843511100636 ()
01-01-0010

  • Bone graft packing block

OMEGO - 09120077180083

The OMEGO is a robotic pre-gait therapy system for the rehabilitation of patients with neurologic disorders.
tyromotion GmbH
1
In Commercial Distribution

  • 09120077180083 ()


  • Treadmill/elliptical gait rehabilitation system

OCELOT - 10705034189727

OCELOT STACKABLE CAGE SYSTEM FILLER BLOCK
DEPUY SPINE, LLC
273400900
In Commercial Distribution

  • 10705034189727 ()
273400900

  • Bone graft packing block

NxSTEP - 00718175004852

NxSTEP Unweighing System, 115VAC
BIODEX MEDICAL SYSTEMS, INC.
950-485
In Commercial Distribution

  • 00718175004852 ()
950-485

  • Mobile gait rehabilitation system, harness-support

NxSTEP - 00718175004845

NxSTEP Unweighing System, without Harness
BIODEX MEDICAL SYSTEMS, INC.
950-484
In Commercial Distribution

  • 00718175004845 ()
950-484

  • Mobile gait rehabilitation system, harness-support

NxSTEP - 00718175004807

NxSTEP Unweighing System
BIODEX MEDICAL SYSTEMS, INC.
945-480
In Commercial Distribution

  • 00718175004807 ()
945-480

  • Mobile gait rehabilitation system, harness-support

NA - 08800042415952

Platform
Medyssey Co., Ltd.
NAPF-001
In Commercial Distribution

  • 08800042415952 ()


  • Bone graft packing block
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