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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Resorbable Collagen Membrane
COLLAGEN MATRIX, INC.
OSTEOF15x20
In Commercial Distribution

  • 00850011613009 ()

  • 15mm x 20mm


  • Collagen dental regeneration membrane
WaffleGrip Trendelenburg Positioning Kit for Electrosurgery, 10 Pack
AUGUSTINE TEMPERATURE MANAGEMENT LLC
A302
In Commercial Distribution

  • 00850011479711 ()
A302

  • Operating table non-slip back pad
WaffleGrip PadLock Bracket Set for WaffleGrip Trendelenburg Positioning Kit for Warming Pad
AUGUSTINE TEMPERATURE MANAGEMENT LLC
A330
In Commercial Distribution

  • 00850011479643 ()
A330

  • Operating table non-slip back pad
WaffleGrip Bracket Set
AUGUSTINE TEMPERATURE MANAGEMENT LLC
2084054
In Commercial Distribution

  • 00850011479636 ()
2084054

  • Operating table non-slip back pad
PST500 Integrated Warming Pad
AUGUSTINE TEMPERATURE MANAGEMENT LLC
2083521
In Commercial Distribution

  • 00850011479629 ()
2083521

  • Electric pad whole-body heating system
TS7000 Integrated Warming Pad
AUGUSTINE TEMPERATURE MANAGEMENT LLC
2083520
In Commercial Distribution

  • 00850011479612 ()
2083520

  • Electric pad whole-body heating system
Universal Warming Blanket
AUGUSTINE TEMPERATURE MANAGEMENT LLC
2083519
In Commercial Distribution

  • 00850011479605 ()
2083519

  • Electric pad whole-body heating system
Lower Body Warming Blanket
AUGUSTINE TEMPERATURE MANAGEMENT LLC
2083518
In Commercial Distribution

  • 00850011479599 ()
2083518

  • Electric pad whole-body heating system
Temperature Management Controller MP
AUGUSTINE TEMPERATURE MANAGEMENT LLC
2083516
In Commercial Distribution

  • 00850011479582 ()
2083516

  • Electric pad whole-body heating system
WaffleGrip Disposables for Warming Pad
AUGUSTINE TEMPERATURE MANAGEMENT LLC
2083515
In Commercial Distribution

  • 00850011479575 ()
2083515

  • Operating table non-slip back pad
WaffleGrip Trendelenburg Positioning Kit + BackSaver Slide Sheet for Warming Pad, 10 Pack
AUGUSTINE TEMPERATURE MANAGEMENT LLC
A307
In Commercial Distribution

  • 00850011479506 ()
A307

  • Operating table non-slip back pad
WaffleGrip Trendelenburg Positioning Kit + Backsaver Slide Sheet, 10 Pack
AUGUSTINE TEMPERATURE MANAGEMENT LLC
A301
In Commercial Distribution

  • 00850011479100 ()
A301

  • Operating table non-slip back pad
HotDog Temperature Management Controller - Multiport
AUGUSTINE TEMPERATURE MANAGEMENT LLC
WC77
In Commercial Distribution

  • 00850011479025 ()
WC77

  • Electric pad whole-body heating system
HotDog Temperature Management Controller - Single Port
AUGUSTINE TEMPERATURE MANAGEMENT LLC
WC71
In Commercial Distribution

  • 00850011479018 ()
WC71

  • Electric pad whole-body heating system
Ecoil ID - 1.5T GE - M64ERA8-P
DXTX MEDICAL INC
M64ERA8-P
In Commercial Distribution

  • 00850011472224 ()


  • MRI system coil, radio-frequency
Ecoil ID - FID SYM FRU
DXTX MEDICAL INC
FID SYM FRU
In Commercial Distribution

  • 00850011472217 ()


  • MRI system coil, radio-frequency
Ecoil ID - FID SYM
DXTX MEDICAL INC
FID SYM
In Commercial Distribution

  • 00850011472200 ()


  • MRI system coil, radio-frequency
Ecoil ID - STID TIM 30 - 8626694
DXTX MEDICAL INC
STID TIM 30
In Commercial Distribution

  • 00850011472194 ()


  • MRI system coil, radio-frequency
Ecoil ID - STID TIM 30 FRU - 8624855
DXTX MEDICAL INC
STID TIM 30 FRU
In Commercial Distribution

  • 00850011472187 ()


  • MRI system coil, radio-frequency
Endorectal MRI Coil for 3.0T MR Imaging of the Prostate (eCoil®), alternate Philips package catalog number 4522-132-64752 for box of 5
DXTX MEDICAL INC
BPX 30
In Commercial Distribution

  • 10850011472177 ()
  • 00850011472170 ()
BPX 30

  • MRI system coil, radio-frequency
Disposable Prostate Probe - 1.5T - BPX15-50
DXTX MEDICAL INC
BPX 15-50
In Commercial Distribution

  • 10850011472160 ()
  • 00850011472163 ()


  • MRI system coil, radio-frequency
Disposable Colon Probe - PCC-15
DXTX MEDICAL INC
PCC 15
In Commercial Distribution

  • 10850011472153 ()
  • 00850011472156 ()


  • MRI system coil, radio-frequency
Endorectal MRI Coil for 1.5T MR Imaging of the Prostate (eCoil®), alternate Philips package catalog number 4522-132-70682 for box of 5
DXTX MEDICAL INC
BPX 15
In Commercial Distribution

  • 00850011472149 ()
  • 10850011472146 ()
BPX 15

  • MRI system coil, radio-frequency
Disposable Cervix Probe - BCR-15
DXTX MEDICAL INC
BCR 15
In Commercial Distribution

  • 10850011472139 ()
  • 00850011472132 ()


  • MRI system coil, radio-frequency
Disposable Prostate Probe - 1.5T Philips - 4522-132-70681
DXTX MEDICAL INC
4522-132-70681
In Commercial Distribution

  • 10850011472122 ()
  • 00850011472125 ()


  • MRI system coil, radio-frequency
Disposable Prostate Probe - 3.0T Philips - 4522-132-64751
DXTX MEDICAL INC
4522-132-64751
In Commercial Distribution

  • 10850011472115 ()
  • 00850011472118 ()


  • MRI system coil, radio-frequency
3.0T Ingenia Endorectal Coil Interface Device System (eCoil®) - Philips
DXTX MEDICAL INC
9896-030-19032
In Commercial Distribution

  • 00850011472101 ()
9896-030-19032

  • MRI system coil, radio-frequency
3.0T Ingenia Endorectal Coil Interface Device (eCoil®) - Philips
DXTX MEDICAL INC
4598-001-13812
In Commercial Distribution

  • 00850011472095 ()
4598-001-13812

  • MRI system coil, radio-frequency
1.5T Ingenia Endorectal Coil Interface Device System (eCoil®) - Philips
DXTX MEDICAL INC
9896-030-19122
In Commercial Distribution

  • 00850011472088 ()
9896-030-19122

  • MRI system coil, radio-frequency
Ecoil ID - 1.5T GE - M64ERA8-HD
DXTX MEDICAL INC
M64ERA8-HD
In Commercial Distribution

  • 00850011472071 ()


  • MRI system coil, radio-frequency
Ecoil ID - 3.0T GE - M128ERA8-HD
DXTX MEDICAL INC
M128ERA8-HD
In Commercial Distribution

  • 00850011472064 ()


  • MRI system coil, radio-frequency
eCoil ID - 1.5T Philips Ingenia Assy - 9896-030-19121
DXTX MEDICAL INC
9896-030-19121
In Commercial Distribution

  • 00850011472057 ()


  • MRI system coil, radio-frequency
Ecoil ID - 3.0T Philips Ingenia Assy - 9896-030-19031
DXTX MEDICAL INC
9896-030-19031
In Commercial Distribution

  • 00850011472040 ()


  • MRI system coil, radio-frequency
Ecoil ID - 3.0T Philips Ingenia FRU - 4598-001-13811
DXTX MEDICAL INC
4598-001-13801
In Commercial Distribution

  • 00850011472033 ()


  • MRI system coil, radio-frequency
Ecoil ID - 1.5T Philips Ingenia FRU - 4598-001-13801
DXTX MEDICAL INC
4598-001-13801
In Commercial Distribution

  • 00850011472026 ()


  • MRI system coil, radio-frequency
1.5T Ingenia Endorectal Coil Interface Device (eCoil®) - Philips
DXTX MEDICAL INC
4598-001-13802
In Commercial Distribution

  • 00850011472019 ()
4598-001-13802

  • MRI system coil, radio-frequency
BioBrush Powered Debridement Device (Large Brush)
OSTEOREMEDIES, LLC
DDBK02
In Commercial Distribution

  • 00850011453285 ()
DDBK02

  • Arthroscopic shaver/electrosurgical system
REMEDY® Stemmed Knee - Adjunct Base
OSTEOREMEDIES, LLC
RSKABASE
In Commercial Distribution

  • 00850011453278 ()
RSKABASE

  • Instrument tray, reusable
REMEDY® Stem Extension Trial 230, 13/11 OD
OSTEOREMEDIES, LLC
RTS230
In Commercial Distribution

  • 00850011453261 ()
RTS230

  • Knee tibia prosthesis trial, reusable
REMEDY® Stem Extension Trial 150, 13/11 OD
OSTEOREMEDIES, LLC
RTS150
In Commercial Distribution

  • 00850011453254 ()
RTS150

  • Knee tibia prosthesis trial, reusable
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