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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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XL Pacer - 00858101008285

Gait Trainer
RIFTON EQUIPMENT
K650
In Commercial Distribution

  • 00858101008285 ()


  • Gait rehabilitation frame, manual

Large Pacer - 00858101008278

Gait Trainer
RIFTON EQUIPMENT
K640
In Commercial Distribution

  • 00858101008278 ()


  • Gait rehabilitation frame, manual

Medium Pacer - 00858101008261

Gait Trainer
RIFTON EQUIPMENT
K630
In Commercial Distribution

  • 00858101008261 ()


  • Gait rehabilitation frame, manual

SafeGait Active 360 Dynamic Mobility Trainer - 00860012112838

SafeGait Active 360 system (Model SGA360) is designed to assist a patient with walking/balance impediments to exercise and/or regain normal gait. SafeGait Active 360 system tethers patients with a dedicated harness hanging from a powered pneumatic braking device on the overhead aluminum rails moved by pulling force from the patient. SafeGait Active 360 system reduces clinician’s workload when helping patients to exercise or relearn the gait in a safe 3D environment. SafeGait Active 360 system shall only be operated by trained clinicians, therapists or DIH staff.
DIH TECHNOLOGY INC.
SGA360
In Commercial Distribution

  • 00860012112838 ()


  • Gait rehabilitation frame, electric

SafeGait Active Dynamic Mobility Trainer - 00860012112821

SafeGait Active S1000 system (Model SGAS1000) is designed to assist a patient with some impediments in walking/balance to exercise and/or to regain normal gait. SafeGait Active S1000 system tethers patients with a dedicated harness hanging from a powered pneumatic braking device on the overhead steel rails moved by pulling force from the patient. SafeGait Active S1000 system reduces clinician’s workload when helping patients to exercise or relearn the gait in a safe 3D environment. SafeGait Active S1000 system shall only be operated by trained clinicians, therapists or DIH staff.
DIH TECHNOLOGY INC.
SGAS1000
In Commercial Distribution

  • 00860012112821 ()


  • Gait rehabilitation frame, electric

SafeGait 360 Balance and Mobility Trainer - 00860012112814

SafeGait 360 system (Model SG360) is a body weight support system designed to assist a patient with a walking/balance disability to regain mobility via exercise and gait training. SafeGait 360 system tethers patients with a dedicated harness hanging from a powered device running on the overhead aluminum rails to offload the patient’s weight to various levels configurable via a computer or a handheld device. SafeGait 360 system reduces clinician’s workload when helping patients to exercise or relearn the gait in a safe 3D environment. SafeGait 360 system shall only be operated by trained clinicians, therapists or DIH staff.
DIH TECHNOLOGY INC.
SG360
In Commercial Distribution

  • 00860012112814 ()


  • Gait rehabilitation frame, electric

ACUSON Origin Diagnostic Ultrasound System - 04056869996295

No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
11668590
In Commercial Distribution

  • 04056869996295 ()


  • General-purpose ultrasound imaging system

Origin Coxa Vara Hip Stem - 09348215013226

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1804
In Commercial Distribution

  • 09348215013226 ()


  • Coated femoral stem prosthesis, modular

Origin Coxa Vara Hip Stem - 09348215013219

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1604
In Commercial Distribution

  • 09348215013219 ()


  • Coated femoral stem prosthesis, modular

Origin Coxa Vara Hip Stem - 09348215013202

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1504
In Commercial Distribution

  • 09348215013202 ()


  • Coated femoral stem prosthesis, modular

Origin Coxa Vara Hip Stem - 09348215013196

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1404
In Commercial Distribution

  • 09348215013196 ()


  • Coated femoral stem prosthesis, modular

Origin Coxa Vara Hip Stem - 09348215013189

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1304
In Commercial Distribution

  • 09348215013189 ()


  • Coated femoral stem prosthesis, modular

Origin Coxa Vara Hip Stem - 09348215013172

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1204
In Commercial Distribution

  • 09348215013172 ()


  • Coated femoral stem prosthesis, modular

Origin Coxa Vara Hip Stem - 09348215013165

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1104
In Commercial Distribution

  • 09348215013165 ()


  • Coated femoral stem prosthesis, modular

Origin Coxa Vara Hip Stem - 09348215013158

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1004
In Commercial Distribution

  • 09348215013158 ()


  • Coated femoral stem prosthesis, modular

Origin Coxa Vara Hip Stem - 09348215013141

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-0904
In Commercial Distribution

  • 09348215013141 ()


  • Coated femoral stem prosthesis, modular

Origin Short Neck Hip Stem - 09348215023928

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1805
In Commercial Distribution

  • 09348215023928 ()


  • Coated femoral stem prosthesis, modular

Origin Short Neck Hip Stem - 09348215023911

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1605
In Commercial Distribution

  • 09348215023911 ()


  • Coated femoral stem prosthesis, modular

Origin Short Neck Hip Stem - 09348215023904

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1505
In Commercial Distribution

  • 09348215023904 ()


  • Coated femoral stem prosthesis, modular

Origin Short Neck Hip Stem - 09348215023898

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1405
In Commercial Distribution

  • 09348215023898 ()


  • Coated femoral stem prosthesis, modular

Origin Short Neck Hip Stem - 09348215023881

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1305
In Commercial Distribution

  • 09348215023881 ()


  • Coated femoral stem prosthesis, modular

Origin Short Neck Hip Stem - 09348215023874

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1205
In Commercial Distribution

  • 09348215023874 ()


  • Coated femoral stem prosthesis, modular

Origin Short Neck Hip Stem - 09348215023867

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1105
In Commercial Distribution

  • 09348215023867 ()


  • Coated femoral stem prosthesis, modular

Origin Short Neck Hip Stem - 09348215023850

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1005
In Commercial Distribution

  • 09348215023850 ()


  • Coated femoral stem prosthesis, modular

Origin Short Neck Hip Stem - 09348215023843

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-0905
In Commercial Distribution

  • 09348215023843 ()


  • Coated femoral stem prosthesis, modular

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

Origin DAA Stem, Standard Offset - 09348215088477

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1312
In Commercial Distribution

  • 09348215088477 ()


  • Coated femoral stem prosthesis, modular

Origin DAA Stem, High Offset - 09348215088460

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1213
In Commercial Distribution

  • 09348215088460 ()


  • Coated femoral stem prosthesis, modular

Origin DAA Stem, Standard Offset - 09348215088453

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1212
In Commercial Distribution

  • 09348215088453 ()


  • Coated femoral stem prosthesis, modular

Origin DAA Stem, High Offset - 09348215088446

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1113
In Commercial Distribution

  • 09348215088446 ()


  • Coated femoral stem prosthesis, modular

Origin DAA Stem, Standard Offset - 09348215088439

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1112
In Commercial Distribution

  • 09348215088439 ()


  • Coated femoral stem prosthesis, modular

Origin DAA Stem, High Offset - 09348215088422

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1013
In Commercial Distribution

  • 09348215088422 ()


  • Coated femoral stem prosthesis, modular

Origin DAA Stem, Standard Offset - 09348215088415

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1012
In Commercial Distribution

  • 09348215088415 ()


  • Coated femoral stem prosthesis, modular

Origin DAA Stem, High Offset - 09348215088408

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-0913
In Commercial Distribution

  • 09348215088408 ()


  • Coated femoral stem prosthesis, modular

Origin DAA Stem, Standard Offset - 09348215088392

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-0912
In Commercial Distribution

  • 09348215088392 ()


  • Coated femoral stem prosthesis, modular

Origin DAA Stem, High Offset - 09348215088385

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-0813
In Commercial Distribution

  • 09348215088385 ()


  • Coated femoral stem prosthesis, modular

Origin DAA Stem, Standard Offset - 09348215088378

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-0812
In Commercial Distribution

  • 09348215088378 ()


  • Coated femoral stem prosthesis, modular

Origin Short Neck Hip Stem - 09348215083533

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-0805
In Commercial Distribution

  • 09348215083533 ()


  • Coated femoral stem prosthesis, modular

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
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