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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CONNECTOR X1001061 METRX ARM BLADE
MEDTRONIC SOFAMOR DANEK, INC.
X1001061
In Commercial Distribution

  • 00721902445927 ()


  • Orthopaedic instrument surgical connector
CASE 3490074 MSD WIRE 1.0MM CADDY LID
MEDTRONIC SOFAMOR DANEK, INC.
3490074
In Commercial Distribution

  • 00721902445903 ()


  • Instrument tray, reusable
CASE 3490020 MSD WIRE BASE
MEDTRONIC SOFAMOR DANEK, INC.
3490020
In Commercial Distribution

  • 00721902445873 ()


  • Instrument tray, reusable
No Description
Merit Medical Systems, Inc.
00884450196168
In Commercial Distribution

  • 20884450196162 ()
  • 10884450196165 ()
  • 00884450196168 ()
K02-01466A

  • General-purpose syringe, single-use
SCREW 8481743 CANNULATED BONE 7.5MM TI
MEDTRONIC SOFAMOR DANEK, INC.
8481743
Not in Commercial Distribution

  • 00721902443671 ()


  • Spinal bone screw, non-bioabsorbable
SCREW 8481738 CANNULATED BONE 7.5MM TI
MEDTRONIC SOFAMOR DANEK, INC.
8481738
Not in Commercial Distribution

  • 00721902443619 ()


  • Spinal bone screw, non-bioabsorbable
SCREW 8481733 CANNULATED BONE 7.5MM TI
MEDTRONIC SOFAMOR DANEK, INC.
8481733
Not in Commercial Distribution

  • 00721902443572 ()


  • Spinal bone screw, non-bioabsorbable
No Description
Merit Medical Systems, Inc.
00884450194348
In Commercial Distribution

  • 10884450194345 ()
  • 00884450194348 ()
  • 20884450194342 ()
C408655

  • General-purpose syringe, single-use
SCREW 8481725 CANNULATED BONE 7.5MM TI
MEDTRONIC SOFAMOR DANEK, INC.
8481725
Not in Commercial Distribution

  • 00721902443497 ()


  • Spinal bone screw, non-bioabsorbable
SCREW 8481723 CANNULATED BONE 7.5MM TI
MEDTRONIC SOFAMOR DANEK, INC.
8481723
Not in Commercial Distribution

  • 00721902443459 ()


  • Spinal bone screw, non-bioabsorbable
SCREW 8481645 CANNULATED BONE 6.5MM TI
MEDTRONIC SOFAMOR DANEK, INC.
8481645
Not in Commercial Distribution

  • 00721902443343 ()


  • Spinal bone screw, non-bioabsorbable
SCREW 8481640 CANNULATED BONE 6.5MM TI
MEDTRONIC SOFAMOR DANEK, INC.
8481640
Not in Commercial Distribution

  • 00721902443305 ()


  • Spinal bone screw, non-bioabsorbable
SCREW 8481623 CANNULATED BONE 6.5MM TI
MEDTRONIC SOFAMOR DANEK, INC.
8481623
Not in Commercial Distribution

  • 00721902443008 ()


  • Spinal bone screw, non-bioabsorbable
14MM CANC DRILL BIT
MEDTRONIC SOFAMOR DANEK, INC.
X1201025
In Commercial Distribution

  • 00721902440915 ()


  • Surgical drill guide, reusable
SCREW 6960113 PRSTG BONE FAST 4.5X13MM
MEDTRONIC SOFAMOR DANEK, INC.
6960113
In Commercial Distribution

  • 00721902440250 ()

  • Length: 13.0 Millimeter
  • Width: 4.5 Millimeter


  • Cervical total intervertebral disc prosthesis, modular
LP20 PACKAGE,PACING,ENGL,DOM
PHYSIO-CONTROL, INC.
70402
Not in Commercial Distribution

  • 00721902439339 ()
70402-000030

  • Physiologic-monitoring defibrillation system
VERTEX SHORT DRILL GUIDE
MEDTRONIC SOFAMOR DANEK, INC.
X1201022
In Commercial Distribution

  • 00721902439131 ()


  • Surgical drill guide, reusable
7MM INSERTER
MEDTRONIC SOFAMOR DANEK, INC.
YIB0801-025
Not in Commercial Distribution

  • 00721902437717 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable
12MM HOLLOW REAMER
MEDTRONIC SOFAMOR DANEK, INC.
YIB1299-103
Not in Commercial Distribution

  • 00721902436048 ()


  • Orthopaedic broach
12MM/8MM WORKING CHANNEL
MEDTRONIC SOFAMOR DANEK, INC.
YIB1299-101
Not in Commercial Distribution

  • 00721902436017 ()


  • Orthopaedic rod reducer
14MM/10MM WORKING CHANNEL
MEDTRONIC SOFAMOR DANEK, INC.
YIB0300-13
Not in Commercial Distribution

  • 00721902435966 ()


  • Orthopaedic rod reducer
16MM HOLLOW REAMER
MEDTRONIC SOFAMOR DANEK, INC.
YIB0200-008
Not in Commercial Distribution

  • 00721902435843 ()


  • Orthopaedic broach
16MM/10MM WORKING CHANNEL
MEDTRONIC SOFAMOR DANEK, INC.
YIB0200-006
Not in Commercial Distribution

  • 00721902435744 ()


  • Orthopaedic rod reducer
14MM HOLLOW REAMER
MEDTRONIC SOFAMOR DANEK, INC.
YIB0200-003
Not in Commercial Distribution

  • 00721902435683 ()


  • Orthopaedic broach
ATL 4.5X22MM ST VA SCR
MEDTRONIC SOFAMOR DANEK, INC.
X876-862
In Commercial Distribution

  • 00721902429767 ()

  • Length: 22.0 Millimeter
  • Outer Diameter: 4.5 Millimeter


  • Spinal bone screw, non-bioabsorbable
ATL 4.0X22MM ST VA SCR X876-822
MEDTRONIC SOFAMOR DANEK, INC.
X876-822
In Commercial Distribution

  • 00721902429743 ()

  • Length: 22.0 Millimeter
  • Outer Diameter: 4.0 Millimeter


  • Spinal bone screw, non-bioabsorbable
ATL 4.5X22MM ST FA SCR
MEDTRONIC SOFAMOR DANEK, INC.
X876-762
In Commercial Distribution

  • 00721902429712 ()

  • Length: 22.0 Millimeter
  • Outer Diameter: 4.0 Millimeter


  • Spinal bone screw, non-bioabsorbable
ATL 4.0X22MM ST FA SCR
MEDTRONIC SOFAMOR DANEK, INC.
X876-722
In Commercial Distribution

  • 00721902429675 ()

  • Outer Diameter: 4.0 Millimeter
  • Length: 22.0 Millimeter


  • Spinal bone screw, non-bioabsorbable
18MM GRAFT PLATE
MEDTRONIC SOFAMOR DANEK, INC.
853-418
In Commercial Distribution

  • 00721902427381 ()

  • Width: 18.0 Millimeter


  • Orthopaedic fixation plate, non-bioabsorbable
PLATE 853-412 12MM GRFT PLT
MEDTRONIC SOFAMOR DANEK, INC.
853-412
In Commercial Distribution

  • 00721902427350 ()

  • Width: 12.0 Millimeter


  • Orthopaedic fixation plate, non-bioabsorbable
TRAUMA 853-012 12MM OD PLATE
MEDTRONIC SOFAMOR DANEK, INC.
853-012
In Commercial Distribution

  • 00721902427282 ()

  • Width: 12.0 Millimeter


  • Orthopaedic fixation plate, non-bioabsorbable
INSTRUMENT 2900356 15MM SHAVER
MEDTRONIC SOFAMOR DANEK, INC.
2900356
In Commercial Distribution

  • 00721902411304 ()


  • Bone curette, reusable
INSTRUMENT 2900353 12MM SHAVER
MEDTRONIC SOFAMOR DANEK, INC.
2900353
In Commercial Distribution

  • 00721902410895 ()


  • Bone curette, reusable
INSTRUMENT 2900351 10MM SHAVER
MEDTRONIC SOFAMOR DANEK, INC.
2900351
In Commercial Distribution

  • 00721902410765 ()


  • Bone curette, reusable
HOLDER X0302012 ROD 5.5MM
MEDTRONIC SOFAMOR DANEK, INC.
X0302012
In Commercial Distribution

  • 00721902410529 ()


  • Orthopaedic rod reducer
SPREADER 2900257 14MMX12
MEDTRONIC SOFAMOR DANEK, INC.
2900257
In Commercial Distribution

  • 00721902410017 ()


  • Bone distraction forceps
SPREADER 2900256 12MMX12
MEDTRONIC SOFAMOR DANEK, INC.
2900256
In Commercial Distribution

  • 00721902410000 ()


  • Bone distraction forceps
SPREADER 2900254 14MMX6
MEDTRONIC SOFAMOR DANEK, INC.
2900254
In Commercial Distribution

  • 00721902409981 ()


  • Bone distraction forceps
INSTRUMENT 2900251 SPREADER 8MM
MEDTRONIC SOFAMOR DANEK, INC.
2900251
In Commercial Distribution

  • 00721902409950 ()


  • Bone distraction forceps
INSTRUMENT 2900250 SPREADER 6MM
MEDTRONIC SOFAMOR DANEK, INC.
2900250
In Commercial Distribution

  • 00721902409943 ()


  • Bone distraction forceps
CASE 9562012 METRX SCOPE
MEDTRONIC SOFAMOR DANEK, INC.
9562012
In Commercial Distribution

  • 00721902402937 ()


  • Instrument tray, reusable
CASE 9560701 METRX LARGE TUBES TRAY
MEDTRONIC SOFAMOR DANEK, INC.
9560701
In Commercial Distribution

  • 00721902402869 ()


  • Instrument tray, reusable
LP12AABBBBAABABBAABAAAAALP12 MONITOR-DEFIB
PHYSIO-CONTROL, INC.
97400
Not in Commercial Distribution

  • 00721902399572 ()
97400-000251

  • Physiologic-monitoring defibrillation system
ST X 11MM DEPTH X 9MM CUTTER
MEDTRONIC SOFAMOR DANEK, INC.
X0302409
In Commercial Distribution

  • 00721902397974 ()


  • Orthopaedic knife
ST X 11MM DEPTH X 6MM CUTTER
MEDTRONIC SOFAMOR DANEK, INC.
X0302406
In Commercial Distribution

  • 00721902397905 ()


  • Orthopaedic knife
MICROPITUITARY X0102005 DOWNBITING 2MM
MEDTRONIC SOFAMOR DANEK, INC.
X0102005
In Commercial Distribution

  • 00721902397196 ()


  • Orthopaedic joint/limb rongeur
COUNTERTORQUE W/ROTATED HANDLE
MEDTRONIC SOFAMOR DANEK, INC.
X1201009
In Commercial Distribution

  • 00721902384356 ()


  • Orthopaedic counter-torque/rod-pushing instrument
SPACER 8916840 40MM CENTER LG
MEDTRONIC SOFAMOR DANEK, INC.
8916840
In Commercial Distribution

  • 00721902380181 ()

  • 40mm


  • Vertebral body prosthesis
SPACER 8916820 20MM CENTER LG
MEDTRONIC SOFAMOR DANEK, INC.
8916820
In Commercial Distribution

  • 00721902380150 ()

  • 20mm


  • Vertebral body prosthesis
SPACER 8916810 10MM CENTER LG
MEDTRONIC SOFAMOR DANEK, INC.
8916810
In Commercial Distribution

  • 00721902380136 ()

  • 10mm


  • Vertebral body prosthesis
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