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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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rexpander 1.6 x 13
Rex Implants, Inc.
1.6 x 13
In Commercial Distribution

  • D894BE030 ()

  • Height: 13 Millimeter
  • Width: 1.6 Millimeter
BE-03

  • Maxillofacial bone separator
rexpander 1.6 x 11
Rex Implants, Inc.
1.6 x 11
In Commercial Distribution

  • D894BE020 ()

  • Height: 11 Millimeter
  • Width: 1.6 Millimeter
BE-02

  • Maxillofacial bone separator
rexpander 1.6 x 9
Rex Implants, Inc.
1.6 x 9
In Commercial Distribution

  • D894BE010 ()

  • Width: 1.6 Millimeter
  • Height: 9 Millimeter
BE-01

  • Maxillofacial bone separator
cortiQ PRO is a system that uses g.HIamp to map high-gamma broad band brain activity while running an experimental paradigm. The software helps to identify electrode positions coding differences in brain activity by means of experimental paradigm. cortiQ PRO performs the signal analysis in real-time and compares the high-gamma broad band activity during specific tasks. Then it performs a statistical analysis and visualizes electrodes coding the information that are statistically significant. It is abstracted from technical details of data acquisition, channel order and signal processing assuring robust and efficient measurements.
g.tec medical engineering GmbH
TD 1.x
In Commercial Distribution

  • EBCI80600 ()


  • Electroencephalographic spectrum analyser
The g.Estim FES is a programmable constant-current stimulator that can deliver electrical pulses with alternating polarities, lengths, amplitudes as well as trains of such pulses. The applied part is galvanic isolated. The stimulator is powered by a combination of USB bus-power and battery power. The host computer must use Microsoft Windows. The stimulator is controlled via a software API that uses a USB connection. A host application can be situated on top of the API and can control the stimulator.
g.tec medical engineering GmbH
TD 1.x
In Commercial Distribution

  • EBCI11700 ()
1170

  • Physical therapy transcutaneous neuromuscular electrical stimulation system
The SEDECAL X URS Radiographic System is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.
SEDECAL
SEDECAL X URS
In Commercial Distribution



  • Stationary basic diagnostic x-ray system, analogue
The SEDECAL X (URS) Radiographic System is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.
SEDECAL
SEDECAL X (URS)
In Commercial Distribution

  • 08436046000933 ()


  • Stationary basic diagnostic x-ray system, analogue
Diamond FG
EDENTA ETABLISSEMENT
EDENTA SET X
In Commercial Distribution

  • E312EDENTASETX101 ()
  • E312EDENTASETX1 ()


  • Diamond dental bur, reusable
BTE-TRT
audifon GmbH & Co. KG
arriva X TRT
Not in Commercial Distribution

  • EADF004658295733517201 ()
004658-2957-335-1720

  • Air-conduction hearing aid, behind-the-ear
BTE-TRT
audifon GmbH & Co. KG
arriva X TRT
Not in Commercial Distribution

  • EADF004658295732117201 ()
004658-2957-321-1720

  • Air-conduction hearing aid, behind-the-ear
BTE-TRT
audifon GmbH & Co. KG
arriva X TRT
Not in Commercial Distribution

  • EADF004658295731517201 ()
004658-2957-315-1720

  • Air-conduction hearing aid, behind-the-ear
BTE-TRT
audifon GmbH & Co. KG
arriva X TRT
Not in Commercial Distribution

  • EADF004658295731117201 ()
004658-2957-311-1720

  • Air-conduction hearing aid, behind-the-ear
BTE-TRT
audifon GmbH & Co. KG
arriva X TRT
Not in Commercial Distribution

  • EADF004658295732517201 ()
004658-2957-325-1720

  • Air-conduction hearing aid, behind-the-ear
BTE-TRT
audifon GmbH & Co. KG
arriva X TRT
Not in Commercial Distribution

  • EADF004658295731317201 ()
004658-2957-313-1720

  • Air-conduction hearing aid, behind-the-ear
Procellera Single Layer Rx, 1" x 1"
Vomaris Wound Care, Inc.
1" x 1"
In Commercial Distribution

  • 00894318002647 ()
  • 10894318002644 ()
VSR-0101

  • Bioelectric wound dressing
Procellera Single Layer Rx, 1.5" x 8"
Vomaris Wound Care, Inc.
1.5" x 8"
In Commercial Distribution

  • 00894318002630 ()
  • 10894318002637 ()
VSR-1508

  • Bioelectric wound dressing
Procellera Single Layer Rx, 1.5" x 10"
Vomaris Wound Care, Inc.
1.5" x 10"
In Commercial Distribution

  • 00894318002623 ()
  • 10894318002620 ()
VSR-1510

  • Bioelectric wound dressing
Procellera Single Layer Rx, 2" x 2"
Vomaris Wound Care, Inc.
2" x 2"
In Commercial Distribution

  • 00894318002616 ()
  • 10894318002613 ()
VSR-0202

  • Bioelectric wound dressing
Procellera Single Layer Rx, 2" x 5"
Vomaris Wound Care, Inc.
2" x 5"
In Commercial Distribution

  • 00894318002609 ()
  • 10894318002606 ()
VSR-0205

  • Bioelectric wound dressing
Procellera Single Layer Rx, 3" x 3"
Vomaris Wound Care, Inc.
3" x 3"
In Commercial Distribution

  • 00894318002593 ()
  • 10894318002590 ()
VSR-0303

  • Bioelectric wound dressing
Procellera Single Layer Rx, 4" x 4"
Vomaris Wound Care, Inc.
4" x 4"
In Commercial Distribution

  • 00894318002586 ()
  • 10894318002583 ()
VSR-0404

  • Bioelectric wound dressing
No Description
SORIN GROUP ITALIA SRL
SEQUESTRATION SET X
In Commercial Distribution

  • 38033178114333 ()
  • 18033178114339 ()
  • 08033178114332 ()


  • Blood donor set, double-pack
No Description
SORIN GROUP ITALIA SRL
SEQUESTRATION SET X
In Commercial Distribution

  • 38033178110526 ()
  • 18033178110522 ()
  • 08033178110525 ()


  • Autotransfusion system blood component processing set
No Description
Dentsply International Inc.
B69 L X
Not in Commercial Distribution

  • D00116636LB69X0 ()
16636

  • Resin artificial teeth
No Description
Dentsply International Inc.
B67 L X
Not in Commercial Distribution

  • D00116636LB67X0 ()
16636

  • Resin artificial teeth
No Description
Dentsply International Inc.
B62 L X
Not in Commercial Distribution

  • D00116636LB62X0 ()
16636

  • Resin artificial teeth
No Description
Dentsply International Inc.
B66 L X
Not in Commercial Distribution

  • D00116636LB66X0 ()
16636

  • Resin artificial teeth
No Description
Dentsply International Inc.
B65 L X
Not in Commercial Distribution

  • D00116636LB65X0 ()
16636

  • Resin artificial teeth
No Description
Dentsply International Inc.
B62 L X
Not in Commercial Distribution

  • D00116356LB62X0 ()
16356

  • Resin artificial teeth
No Description
Dentsply International Inc.
B69 L X
Not in Commercial Distribution

  • D00116356LB69X0 ()
16356

  • Resin artificial teeth
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