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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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Ortho Solutions Extremity Fixation Implants for Osteosysnthesis - 05055662932720

AO QC COMPRESSION SCREW DRILL 12MM
ORTHO SOLUTIONS HOLDINGS LIMITED
OS310204
In Commercial Distribution

  • 05055662932713 ()
  • 05055662932720 ()
OS310204

  • Cannulated surgical drill bit, single-use

Ortho Solutions Extremity Fixation Implants for Osteosysnthesis - 05055662932706

AO QC COMPRESSION SCREW DRILL 18MM
ORTHO SOLUTIONS HOLDINGS LIMITED
OS310203
In Commercial Distribution

  • 05055662932690 ()
  • 05055662932706 ()
OS310203

  • Cannulated surgical drill bit, single-use

ORTHO SOLUTIONS STERILE DRILL BITS - 05055662962536

META SCREW CANN. DRILL LONG 2.0MM
ORTHO SOLUTIONS HOLDINGS LIMITED
OS310101S
In Commercial Distribution

  • 05055662962529 ()
  • 05055662962536 ()
OS310101S

  • Cannulated surgical drill bit, single-use

HALO TRAUMA KIT - 00650551003861

TRAUMA KIT, 1211-1S SMALL SHORT RING, 1206-20 HEADBLOCK, 1206-11 TRACTION BAIL, (2) 1201-43 3" SKULL PINS, 1201-8 TORQUE DRIVER
PMT CORPORATION
1211-6SS1
In Commercial Distribution

  • 00650551003861 ()


  • Cervical spine immobilization system, single-use

N/A - 00643169672857

DRIVER NAV2081K VERT THREADED
MEDTRONIC SOFAMOR DANEK, INC.
NAV2081K
In Commercial Distribution

  • 00643169672857 ()


  • Surgical screwdriver, reusable

GUARDIAN™ - 05414734403078

Screw, 5mm, Burr Hole Cover
ST. JUDE MEDICAL, INC.
6015
In Commercial Distribution

  • 15414734403075 ()
  • 05414734403078 ()
6015

  • Craniofacial fixation plate, non-bioabsorbable, non-customized

GUARDIAN™ - 05414734403061

Cranial Burr Hole Cover Sys.
ST. JUDE MEDICAL, INC.
6010
In Commercial Distribution

  • 05414734403061 ()
6010

  • Craniofacial fixation plate, non-bioabsorbable, non-customized

Balance Advantage Computerized Dynamic Posturography System - 00850017250079

The Computerized Dynamic Posturography (CDP ) system is a clinical balance assessment device that collects and analyzes force and moment data from a balance plate. The balance plate is seated in a dynamic chassis that can move in both translational and rotational directions, under control of the Balance Advantage (BA) software program. The BA software contains both assessment and training modules that can be used during each session. Assessments have set run-times during which they collect data after the “Start” button is pressed, while trainings have customizable run-times varying from 1 minute to 15 minutes. The system is intended to be used by trained clinicians in a hospital or clinical (physical therapy or ENT) environment who operate the software and ensure the safety of the patient. The patient being assessed on the system is placed in a harness. There are three different harness sizes with varying weight limits that can be purchase with the system; standard harness supports up to 300lbs, pediatric is up to 100lbs, and the bariatric supports up to 450lbs. The mechanical components of the system are designed to support up to 500lb patients.
BERTEC CORPORATION
97P-0036
In Commercial Distribution

  • 00850017250079 ()


  • Posturography system platform

Amplion Care Assurance - 00850016398024

Alert Display Driver (ADD) - Configuration 2 (curved)
AMPLION CLINICAL COMMUNICATIONS, INC.
D-ADD-X-2
Not in Commercial Distribution

  • 00850016398024 ()
D-ADD-X-2

  • Nurse call system

Amplion Care Assurance - 00850016398017

Alert Display Driver (ADD) - Configuration 1
AMPLION CLINICAL COMMUNICATIONS, INC.
D-ADD-X-1
Not in Commercial Distribution

  • 00850016398017 ()
D-ADD-X-1

  • Nurse call system
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