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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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Essure is a permanent Birth Control System. One Essure Replacement Kit containing one pouched disposable delivery system with a wound-down insert and a valved introducer.
Bayer Healthcare LLC
ESS305-R1
Not in Commercial Distribution

  • 00888853030517 ()


  • Fallopian tube occlusion insert
Eversense E3 Pouch contains one Eversense E3 Sensor in a Sensor holder.
SENSEONICS, INCORPORATED
102095-81A
In Commercial Distribution

  • 00817491023063 ()


  • Implantable glucose monitoring system sensor
Single Patient Use Filshie® Clip Application Kit for Dual Incision Laparoscopy. Includes one Sterishot II Applicator, 8mm Bladeless Trocar and one pair of Filshie® Clips.
FEMCARE LIMITED
AVM-954
In Commercial Distribution

  • 15055515602371 ()
AVM-954

  • Fallopian tube clip/band
Eversense E3 Sensor Kit contains one Eversense E3 Pouch containing a Sensor in Sensor holder.
SENSEONICS, INCORPORATED
FG-7202-00-301
In Commercial Distribution

  • 00817491022974 ()
FG-7202-00-301

  • Implantable glucose monitoring system sensor
Eversense E3 Sensor Kit contains one Eversense E3 Pouch containing a Sensor in Sensor holder.
SENSEONICS, INCORPORATED
FG-7201-00-301
In Commercial Distribution

  • 00817491022967 ()
FG-7201-00-301

  • Implantable glucose monitoring system sensor
Eversense E3 Sensor Kit contains one Eversense E3 Pouch containing a Sensor in Sensor holder.
SENSEONICS, INCORPORATED
FG-7200-00-301
In Commercial Distribution

  • 00817491022950 ()
FG-7200-00-301

  • Implantable glucose monitoring system sensor
The SpinaLogic is a portable, battery powered, microcontrolled, noninvasive bone growth stimulator indicated as an adjunct electrical treatment to primary lumbar spinal fusion surgery for one or two levels. The SpinaLogic is available in one size.
DJO, LLC
Spinalogic
In Commercial Distribution

  • 00888912011495 ()
01-207-0007

  • Patient-worn bone growth electromagnetic stimulator
Patient cable for transcranial electrical stimulation (TES)
NEXALIN TECHNOLOGY
KS02001
In Commercial Distribution

  • B788KS02001 ()
KS02001

  • Transcranial electrical stimulation system, continuous-current, professional
No Description
NEXALIN TECHNOLOGY
KS02000
In Commercial Distribution

  • B788KS02000 ()
KS02000

  • Transcranial electrical stimulation system, continuous-current, professional
No Description
Ventana Medical Systems, Inc.
09382780001
Not in Commercial Distribution

  • 07613336188019 ()
09382780001

  • Folate receptor alpha (FRa) IVD, antibody
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