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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Standard Tip Hook
UNIFIED SPINE, LLC
501214
In Commercial Distribution

  • M9935012140 ()

  • Large Standard Tip Hook for 5.5mm Rod


  • Bone-screw internal spinal fixation system hook
Standard Tip Hook
UNIFIED SPINE, LLC
501213
In Commercial Distribution

  • M9935012130 ()

  • Medium Standard Tip Hook for 5.5mm Rod


  • Bone-screw internal spinal fixation system hook
Standard Tip Hook
UNIFIED SPINE, LLC
501212
In Commercial Distribution

  • M9935012121 ()

  • Small Standard tip Hook for 5.5mm Rod


  • Bone-screw internal spinal fixation system hook
Standard Tip Hook
UNIFIED SPINE, LLC
501212
In Commercial Distribution

  • M9935012120 ()

  • Small Standard tip Hook for 5.5mm Rod


  • Bone-screw internal spinal fixation system hook
Ratchet QC Driver for Poly-Axial Screw Inst
UNIFIED SPINE, LLC
504110
In Commercial Distribution

  • M9935041100 ()

  • Ratchet QC Driver for Poly-Axial Screw Inst


  • Surgical instrument handle, non-torque-limiting
No Description
Fiagon GmbH
1
Not in Commercial Distribution

  • EFIAE0030010 ()
  • EFIAE0030011 ()
  • 04260759931512 ()

  • Housing for headband ( 86x58mm) elastic tape 49x5mm
  • Weight: 0.036 Kilogram
E 00 3001

  • Multi-purpose stereotactic surgery system
No Description
Fiagon GmbH
1
Not in Commercial Distribution

  • EFIAE0030001 ()

  • Housing for headband ( 86x58mm) elastic tape 49x5mm
  • Weight: 0.036 Kilogram


  • Multi-purpose stereotactic surgery system
Caddy, Small
TITAN SPINE, LLC
1130-1030
Not in Commercial Distribution

  • M682113010300 ()

  • Width: 13.5 Inch
  • Height: 6.5 Inch
  • Length: 15 Inch
  • Small Caddy for Sterile Interbody Fusion Devices
1130-1030

  • Instrument tray, reusable
Caddy, Medium
TITAN SPINE, LLC
1130-1020
Not in Commercial Distribution

  • M682113010200 ()

  • Medium Caddy for Sterile Interbody Fusion Devices
  • Height: 6.5 Inch
  • Width: 13.5 Inch
  • Length: 23 Inch
1130-1020

  • Instrument tray, reusable
Caddy, Medium
TITAN SPINE, LLC
1130-1020
Not in Commercial Distribution

  • 00191375011965 ()

  • Width: 13.5 Inch
  • Medium Caddy for Sterile Interbody Fusion Devices
  • Height: 6.5 Inch
  • Length: 23 Inch
1130-1020

  • Instrument tray, reusable
Caddy, Small
TITAN SPINE, LLC
1130-1030
Not in Commercial Distribution

  • 00191375011958 ()

  • Width: 13.5 Inch
  • Height: 6.5 Inch
  • Length: 15 Inch
  • Small Caddy for Sterile Interbody Fusion Devices
1130-1030

  • Instrument tray, reusable
ERGONOMIC HIGHLY RIGID PLASTIC RING HANDLE WITH RATCHET, RATCHET ACTIVATING/DEACTIVATING KEY, ROTATION MODULE AND HIGH FREQUENCY CONNECTOR
SONTEC INSTRUMENTS, INC.
2901-098
In Commercial Distribution


  • FOR Ø3mm, Ø5mm & Ø10mm TUBE SHAFT INSTRUMENTS
2901-098

  • Laparoscopic surgery handle
ERGONOMIC HIGHLY RIGID PLASTIC RING HANDLE WITH STEPLESS RATCHET, RELEASE KEY, ROTATION MODULE AND HIGH FREQUENCY CONNECTOR
SONTEC INSTRUMENTS, INC.
2901-092
In Commercial Distribution


  • FOR Ø3mm, Ø5mm & Ø10mm TUBE SHAFT INSTRUMENTS
2901-092

  • Laparoscopic surgery handle
AXIAL RING HANDLE WITH RATCHET
SONTEC INSTRUMENTS, INC.
2901-070
In Commercial Distribution


  • FOR Ø3mm, Ø5mm, Ø10mm TUBE SHAFT INSTRUMENTS
2901-070

  • Laparoscopic surgery handle
INSULATED METAL HANDLE ANGLED WITH ROTATING HEAD & HIGH FREQUENCY CONNECTOR
SONTEC INSTRUMENTS, INC.
2901-064
In Commercial Distribution


  • FOR Ø3mm, Ø5mm, Ø10mm TUBE SHAFT INSTRUMENTS
2901-064

  • Laparoscopic surgery handle
ERGONOMIC HIGHLY RIGID PLASTIC RING HANDLE WITH ROTATION MODULE AND HIGH FREQUENCY CONNECTOR
SONTEC INSTRUMENTS, INC.
2901-096
In Commercial Distribution


  • FOR Ø3mm, Ø5mm & Ø10mm TUBE SHAFT INSTRUMENTS
2901-096

  • Laparoscopic surgery handle
AXIAL HANDLE WITH SPRING & RATCHET
SONTEC INSTRUMENTS, INC.
2901-076
In Commercial Distribution


  • FOR Ø3mm, Ø5mm, Ø10mm TUBE SHAFT INSTRUMENTS
2901-076

  • Laparoscopic surgery handle
AXIAL RING HANDLE WITHOUT RATCHET
SONTEC INSTRUMENTS, INC.
2901-074
In Commercial Distribution


  • FOR Ø3mm, Ø5mm, Ø10mm TUBE SHAFT INSTRUMENTS
2901-074

  • Laparoscopic surgery handle
INSULATED METAL HANDLE ANGLED WITH ROTATING HEAD, RATCHET & HIGH FREQUENCY CONNECTOR
SONTEC INSTRUMENTS, INC.
2901-066
In Commercial Distribution


  • FOR Ø3mm, Ø5mm, Ø10mm TUBE SHAFT INSTRUMENTS
2901-066

  • Laparoscopic surgery handle
DRILL GUIDE DOUBLE ENDED TIPS
SONTEC INSTRUMENTS, INC.
1103-162C
In Commercial Distribution

  • 00192896051911 ()

  • 3/1 Tips
  • Length: 4.5 Inch
  • For 2 Millimeter Drill
1103-162C

  • Surgical drill guide, reusable
WIRE END CUTTER DOUBLE SPRING ACTION TUNGSTEN CARBIDE BLADES
SONTEC INSTRUMENTS, INC.
1103-105
In Commercial Distribution

  • 00192896051485 ()

  • Length: 6.25 Inch
  • For wire up to 1.5 Millimeter Tip
1103-105

  • Orthopaedic implantable-device cutter
Screwdriver
NT-Trading GmbH & Co. KG
W 11.THC.DIM
In Commercial Distribution

  • ENTTW11THCDIM1 ()

  • Screwdriver for T-, H-, CAM-, COL-, HIO-,
W 11.THC.DIM

  • Surgical screwdriver, reusable
Screwdriver, ISO shaft
NT-Trading GmbH & Co. KG
W 11.SMU.G03
In Commercial Distribution

  • ENTTW11SMUG031 ()

  • Screwdriver for SEV-, UPR-, UTG-Series, ISO shaft
W 11.SMU.G03

  • Surgical screwdriver, reusable
Screwdriver, ISO shaft
NT-Trading GmbH & Co. KG
W 11. EFK.G50
In Commercial Distribution

  • ENTTW11EFKG501 ()

  • Screwdriver for E-, F-,K-Series, ISO shaft
W 11. EFK.G50

  • Surgical screwdriver, reusable
OSSIO® Drill Pack, 2.8mm For Staple 20x20 mm. Package contains: 1 Instrument Pack.
OSSIO LTD
THN00483
In Commercial Distribution

  • 07290019361138 ()

  • 2.8mm Drill Pack, For Staple 20x20 mm
THN00483

  • Orthopaedic surgical procedure kit, non-medicated, single-use
  • Surgical drill guide, single-use
  • Fluted surgical drill bit, single-use
OSSIO® Drill Pack, 2.8mm For Staple 15x15 mm. Package contains: 1 Instrument Pack.
OSSIO LTD
THN00482
In Commercial Distribution

  • 07290019361121 ()

  • 2.8mm Drill Pack, For Staple 15x15 mm
THN00482

  • Orthopaedic surgical procedure kit, non-medicated, single-use
  • Surgical drill guide, single-use
  • Fluted surgical drill bit, single-use
OSSIO® Drill Pack, 2.8mm For Staple 25x22 mm. Package contains: 1 Instrument Pack.
OSSIO LTD
THN00484
In Commercial Distribution

  • 07290019361145 ()

  • 2.8mm Drill Pack, For Staple 25x22 mm
THN00484

  • Orthopaedic surgical procedure kit, non-medicated, single-use
  • Surgical drill guide, single-use
  • Fluted surgical drill bit, single-use
No Description
SOMNOmedics AG
NGS150
In Commercial Distribution

  • 04250413410064 ()


  • Polysomnograph
The Laerdal Disposable PEEP Valve Assembly is a single patient use accessory for use with all models of Laerdal brand resuscitators to enable clinicians to apply and adjust the level of PEEP therapy being administered to a patient. The PEEP Valve connector is the standard 30 mm ID size
Laerdal Medical AS
20-09502
Not in Commercial Distribution

  • 07045432068696 ()
  • 07045430078680 ()
20-09502

  • PEEP valve, single-use
ROLLER ELECTRODE MONO 21/24.5FR for hysteroscopy, for continuous irrigation sheaths, 21/ 24.5, Fr, electrode shape: roller, fork color red, stem color blue, PACK=1 PC, for use in combination with the Princess resectoscope, unsterile, reusable
Richard Wolf GmbH
865302
Not in Commercial Distribution

  • 04055207040744 ()
8653.02

  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
KNIFE ELECTRODE MONO 26FR 12/30° for resectoscopes, telescope Ø 4mm, for sheaths, intermittent/continuous irrigation, 26/28, Fr, electrode shape: knife, fork color white, stem color red, PACK=1 PC, for E-Line resectoscope, unsterile, reusable
Richard Wolf GmbH
8427192
Not in Commercial Distribution

  • 04055207017357 ()
8427.192

  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
HOOK ELECTRODE MONO 26FR 12/30° for resectoscopes, telescope Ø 4mm, for sheaths, intermittent/continuous irrigation, 26/28, Fr, electrode shape: hook, fork color white, stem color red, PACK=1 PC, for E-Line resectoscope, unsterile, reusable
Richard Wolf GmbH
8427092
Not in Commercial Distribution

  • 04055207017340 ()
8427.092

  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
COAG ELECTRODE MONO 26FR 12/30° for resectoscopes, telescope Ø 4mm, for sheaths, intermittent/continuous irrigation, 26/28, Fr, electrode shape: roller, fork color white, stem color red, PACK=1 PC, for E-Line resectoscope, unsterile, reusable
Richard Wolf GmbH
8427022
Not in Commercial Distribution

  • 04055207017333 ()

  • Outer Diameter: 8.66666666666 Millimeter
8427.022

  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
KNIFE ELECTRODE MONO 26FR 12/30° for resectoscopes, telescope Ø 4mm, for sheaths, intermittent/continuous irrigation, 26/28, Fr, electrode shape: knife, fork color white, stem color red, PACK=1 PC, for E-Line resectoscope, unsterile, reusable
Richard Wolf GmbH
842719
Not in Commercial Distribution

  • 04055207010204 ()
8427.19

  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
COAG ELECTRODE MONO 26FR 12/30° for resectoscopes, telescope Ø 4mm, for sheaths, intermittent/continuous irrigation, 26/28, Fr, electrode shape: roller, fork color white, stem color red, PACK=1 PC, for E-Line resectoscope, unsterile, reusable
Richard Wolf GmbH
842702
Not in Commercial Distribution

  • 04055207010198 ()
8427.02

  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
HOOK ELECTRODE BIPO 22-26FR 12/30° for resectoscope, telescope Ø 4mm, for sheaths, intermittent/continuous irrigation 22/24/26Fr, electrode shape: hook, PACK=1 PC, for Shark Resectoscopes, branch color: blue, stem color: yellow, unsterile, reusable
Richard Wolf GmbH
862309
In Commercial Distribution

  • 04055207010792 ()
862309

  • Endoscopic electrosurgical handpiece/electrode, bipolar, reusable
Constructa Shape Outer Cover, 18" Wide x 20" Deep, Standard or High Contour
SPEX LIMITED
1102-1820-00C-C
In Commercial Distribution

  • 09420051771437 ()


  • Wheelchair seat cushion
Constructa Shape Outer Cover, 18" Wide x 18" Deep, Standard or High Contour
SPEX LIMITED
1102-1818-00C-C
In Commercial Distribution

  • 09420051771352 ()


  • Wheelchair seat cushion
Constructa Shape Outer Cover, 16" Wide x 20" Deep, Standard or High Contour
SPEX LIMITED
1102-1620-00C-C
In Commercial Distribution

  • 09420051771307 ()


  • Wheelchair seat cushion
Constructa Shape Outer Cover, 14" Wide x 18" Deep, Standard or High Contour
SPEX LIMITED
1102-1418-00C-C
In Commercial Distribution

  • 09420051771147 ()


  • Wheelchair seat cushion
Constructa Shape Outer Cover, 14" Wide x 16" Deep, Standard or High Contour
SPEX LIMITED
1102-1416-00C-C
In Commercial Distribution

  • 09420051771109 ()


  • Wheelchair seat cushion
Constructa Shape Cushion, 20" Wide x 22" Deep, Superhigh Contour. Includes Spare Cover
SPEX LIMITED
1102-2022-0CSS
In Commercial Distribution

  • 09420051716193 ()


  • Wheelchair seat cushion
Constructa Shape Cushion, 20" Wide x 20" Deep, Superhigh Contour. Includes Spare Cover
SPEX LIMITED
1102-2020-0CSS
In Commercial Distribution

  • 09420051716186 ()


  • Wheelchair seat cushion
Constructa Shape Cushion, 20" Wide x 22" Deep, High Contour. Includes Spare Cover
SPEX LIMITED
1102-2022-0CHC
In Commercial Distribution

  • 09420051715882 ()


  • Wheelchair seat cushion
Constructa Shape Cushion, 20" Wide x 20" Deep, High Contour. Includes Spare Cover
SPEX LIMITED
1102-2020-0CHC
In Commercial Distribution

  • 09420051715875 ()


  • Wheelchair seat cushion
Constructa Shape Cushion, 18" Wide x 18" Deep, High Contour. Includes Spare Cover
SPEX LIMITED
1102-1818-0CHC
In Commercial Distribution

  • 09420051715851 ()


  • Wheelchair seat cushion
Constructa Shape Cushion, 16" Wide x 20" Deep, High Contour. Includes Spare Cover
SPEX LIMITED
1102-1620-0CHC
In Commercial Distribution

  • 09420051715844 ()


  • Wheelchair seat cushion
Constructa Shape Cushion, 16" Wide x 18" Deep, High Contour. Includes Spare Cover
SPEX LIMITED
1102-1618-0CHC
In Commercial Distribution

  • 09420051715837 ()


  • Wheelchair seat cushion
Constructa Shape Cushion, 16" Wide x 16" Deep, High Contour. Includes Spare Cover
SPEX LIMITED
1102-1616-0CHC
In Commercial Distribution

  • 09420051715820 ()


  • Wheelchair seat cushion
Constructa Shape Cushion, 14" Wide x 18" Deep, High Contour. Includes Spare Cover
SPEX LIMITED
1102-1418-0CHC
In Commercial Distribution

  • 09420051715813 ()


  • Wheelchair seat cushion
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