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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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Headless Compression System 1.5mm Hex Driver Shaft Cannulated
Osteocentric Technologies, Inc.
EX01-0032
In Commercial Distribution

  • 00850015496387 ()
EX01-0032

  • Surgical screwdriver, reusable
Driver, K-Wire, 7.5mm, Catamaran
TENON MEDICAL, INC.
40396
In Commercial Distribution

  • 00850033676495 ()
40396

  • Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated
K-Wire Driver, Catamaran
TENON MEDICAL, INC.
40370
In Commercial Distribution

  • 00850033676358 ()
40370

  • Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated
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
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
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
Midface Reconstruction kit
Materialise NV
SD980.032
In Commercial Distribution

  • 05420060380761 ()
SD980.032

  • Custom-made organ/bone anatomy model/surgical guide kit
Mandible Reconstruction kit
Materialise NV
SD980.031
In Commercial Distribution

  • 05420060380754 ()
SD980.031

  • Custom-made organ/bone anatomy model/surgical guide kit
Titanium 3D Printed Guide, Bone harvesting
Materialise NV
SD980.028
In Commercial Distribution

  • 05420060380747 ()
SD980.028

  • Custom-made orthopaedic/craniofacial surgical guide
DRIVER EX0616017 HEX RETAINING
MEDTRONIC SOFAMOR DANEK, INC.
EX0616017
In Commercial Distribution

  • 00643169834422 ()


  • Surgical screwdriver, reusable
DRIVER EX0616012 SHORTEN T8-T10
MEDTRONIC SOFAMOR DANEK, INC.
EX0616012
In Commercial Distribution

  • 00643169800106 ()


  • Surgical screwdriver, reusable
DRIVER X0416007 NUT 4.75 REDUCER
MEDTRONIC SOFAMOR DANEK, INC.
X0416007
In Commercial Distribution

  • 00643169800045 ()


  • Orthopaedic rod reducer
REDUCER X0416006 4.75
MEDTRONIC SOFAMOR DANEK, INC.
X0416006
In Commercial Distribution

  • 00643169800038 ()


  • Surgical screwdriver, reusable
SCREWDRIVER EX0616081 RETNG BONE 5.5/6.0
MEDTRONIC SOFAMOR DANEK, INC.
EX0616081
In Commercial Distribution

  • 00643169799950 ()


  • Surgical screwdriver, reusable
AWL EX0616054 STRGHT FLEXIBLE-TROCAR TIP
MEDTRONIC SOFAMOR DANEK, INC.
EX0616054
In Commercial Distribution

  • 00643169799660 ()


  • Surgical screwdriver, reusable
DRIVER EX0516002 SHORT PLATE HOLDING PIN
MEDTRONIC SOFAMOR DANEK, INC.
EX0516002
In Commercial Distribution

  • 00643169799585 ()


  • Orthopaedic implant driver
ATHERECTOMY H1-14550 CUTTER DRIVER V03
Covidien LP
H1-14550
In Commercial Distribution

  • 00643169777644 ()


  • Mechanical atherectomy system catheter, peripheral
DRIVER X1215009 TAMPONADE
MEDTRONIC SOFAMOR DANEK, INC.
X1215009
In Commercial Distribution

  • 00643169789326 ()


  • Surgical screwdriver, reusable
REMOVAL BIT X0815014 T27 WITH OBTURATOR
MEDTRONIC SOFAMOR DANEK, INC.
X0815014
In Commercial Distribution

  • 00643169785984 ()


  • Surgical screwdriver, reusable
DRIVER X0714017 6.35MM PROVISIONAL
MEDTRONIC SOFAMOR DANEK, INC.
X0714017
In Commercial Distribution

  • 00643169785960 ()


  • Orthopaedic implant driver
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