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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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SonicOne (O.R. & Clinic) - 00841626100909

SonicOne (O.R. & Clinic) Hospital Grade Power Cord
MISONIX, INC.
E-GPC
In Commercial Distribution

  • 00841626100909 ()


  • Electrical mains power cable

BoneScalpel - 00841626100732

BoneScalpel Probe Cover
MISONIX, INC.
BCM-SS
In Commercial Distribution

  • 00841626100732 ()


  • Cable/lead/sensor/probe cover, non-sterile

SonicOne O.R - 00841626100671

SonicOne O.R Probe Cover
MISONIX, INC.
BCM-H2
In Commercial Distribution

  • 00841626100671 ()


  • Cable/lead/sensor/probe cover, non-sterile

CryoValve® SG Pulmonary Human Heart Valve - 00877234000454

Pulmonary Valve SG The CryoValve SG Pulmonary Human Heart Valve is a human heart valve aseptically recovered from donated human tissue.
Artivion, Inc.
SGPV10
In Commercial Distribution

  • 00877234000454 ()

  • Internal Diameter: Ranges from 6mm to 32mm (allograft specific)
SGPV10

  • Cadaveric heart valve prosthesis, decellularized, non-sterile

CryoValve® SG Pulmonary Human Heart Valve - 00877234000447

Pulmonary Valve and Conduit SG The CryoValve SG Pulmonary Human Heart Valve is a human heart valve aseptically recovered from donated human tissue.
Artivion, Inc.
SGPV00
In Commercial Distribution

  • 00877234000447 ()

  • Internal Diameter: Ranges from 6mm to 32mm (allograft specific)
SGPV00

  • Cadaveric heart valve prosthesis, decellularized, non-sterile

CALICO - 00850044458684

Antimicrobial Gauze
Calico Medical Group LLC
GZ001
In Commercial Distribution

  • 20850044458688 ()
  • 00850044458684 ()
  • 10850044458681 ()
GZ001

  • Woven gauze roll/sheet

FacetLINK MI - 00817329024576

Jamshidi Needle
LINKSPINE, INC.
80-2545
In Commercial Distribution

  • 00817329024576 ()
80-2545

  • Trans-facet-screw internal spinal fixation system, non-sterile

FacetLINK MI - 00817329024569

Cannulated Torque Handle
LINKSPINE, INC.
80-2540
In Commercial Distribution

  • 00817329024569 ()
80-2540

  • Trans-facet-screw internal spinal fixation system, non-sterile

FacetLINK MI - 00817329024552

Reamer
LINKSPINE, INC.
80-2535
In Commercial Distribution

  • 00817329024552 ()
80-2535

  • Trans-facet-screw internal spinal fixation system, non-sterile

FacetLINK MI - 00817329024545

Drill Stop
LINKSPINE, INC.
80-2531
In Commercial Distribution

  • 00817329024545 ()
80-2531

  • Trans-facet-screw internal spinal fixation system, non-sterile
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