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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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Span-America - H93321770

80x42 with handles
SPAN-AMERICA MEDICAL SYSTEMS, INC.
Geomattress Max
Not in Commercial Distribution

  • H93321770 ()
21770

  • Foam bed mattress

eCardiostation Software - B147EC0

Software with CardioStation
UNIVERSAL MEDICAL, INC.
eCardiostation Software
In Commercial Distribution

  • B147EC0 ()


  • Electrocardiography telemetric monitoring system

Prima - D76845009K0

Base with Anatite
KEYSTONE DENTAL, INC.
45009K
Not in Commercial Distribution

  • D76845009K0 ()

  • Outer Diameter 10.0 - 10.0 mm
45009K

  • Dental implant suprastructure, permanent, preformed

Prima - D76845008K0

Base with Anatite
KEYSTONE DENTAL, INC.
45008K
Not in Commercial Distribution

  • D76845008K0 ()

  • Outer Diameter 10.0 - 10.0 mm
45008K

  • Dental implant suprastructure, permanent, preformed

Prima - D76845007K0

Base with Anatite
KEYSTONE DENTAL, INC.
45007K
Not in Commercial Distribution

  • D76845007K0 ()

  • Outer Diameter 10.0 - 10.0 mm
45007K

  • Dental implant suprastructure, permanent, preformed

BioStamp® nPoint - G012BRCA02

Adhesive with hydrogel
Medidata Solutions, Inc.
BRCA02
In Commercial Distribution

  • G012MC0009 ()
  • G012BRCA02 ()
  • B493BRCA02 ()


  • Biomechanical function analysis/rehabilitation software
  • Electromyography telemetric monitoring system transmitter
  • Electrocardiography telemetric monitoring system transmitter
  • Kinesiology/electromyographic sensor set
  • Kinesiology ambulatory recorder

Criticare - B4388100EPUS0

nGenuity with Printer
CRITICARE TECHNOLOGIES, INC.
nGenuity 8100EP
In Commercial Distribution

  • B4388100EPUS0 ()


  • General-purpose multi-parameter bedside monitor

Criticare - B4388100E1US0

nGenuity with CO2
CRITICARE TECHNOLOGIES, INC.
nGenuity 8100E1
In Commercial Distribution

  • B4388100E1US0 ()


  • General-purpose multi-parameter bedside monitor

Arthrex® - 00888867206946

FiberTak with SutureTape
ARTHREX, INC.
AR-3602
In Commercial Distribution

  • 00888867206946 ()
  • M150AR36021 ()
  • 10888867206943 ()
AR-3602

  • Tendon/ligament bone anchor, non-bioabsorbable

BioStamp® - B493BRCA02

Adhesive with hydrogel
MC10, INC.
BRCA02
Not in Commercial Distribution

  • B493MC0009 ()
  • B493BRCA02 ()


  • Biomechanical function analysis/rehabilitation software
  • Electromyography telemetric monitoring system transmitter
  • Electrocardiography telemetric monitoring system transmitter
  • Kinesiology/electromyographic sensor set
  • Kinesiology ambulatory recorder
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