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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Spare part, not medical device, not for sale. Reported for registration of UDI direct marking.
ORTHOFIX SRL
1
In Commercial Distribution

  • 18053504369752 ()
900040

  • External orthopaedic fixation system, reusable
UE XCALIBER ANKLE COMPLETE KIT
ORTHOFIX SRL
1
In Commercial Distribution

  • 18032937169719 ()
99-91647UE

  • External orthopaedic fixation system, single-use
JP XCALIBER ANKLE COMPLETE KIT
ORTHOFIX SRL
1
In Commercial Distribution

  • 18032937169702 ()
99-91647JP

  • External orthopaedic fixation system, single-use, sterile
UE XCALIBER METADIAPHYSEAL COMPLETE KIT
ORTHOFIX SRL
1
In Commercial Distribution

  • 18032937169696 ()
99-91600UE

  • External orthopaedic fixation system, single-use
JP XCALIBER METADIAPHYSEAL COMPLETE KIT
ORTHOFIX SRL
1
In Commercial Distribution

  • 18032937169689 ()
99-91600JP

  • External orthopaedic fixation system, single-use, sterile
US XCALIBER ANKLE COMPLETE KIT
ORTHOFIX SRL
1
In Commercial Distribution

  • 18032937167791 ()
99-91647

  • External orthopaedic fixation system, single-use
US XCALIBER METADIAPHYSEAL COMPLETE KIT
ORTHOFIX SRL
1
In Commercial Distribution

  • 18032937167784 ()
99-91600

  • External orthopaedic fixation system, single-use
XCALIBER/PROCALLUS HYBRID INSTRUMENTS STERIBOX, EMPTY
ORTHOFIX SRL
1
In Commercial Distribution

  • 18032568867299 ()
91980

  • Instrument tray, reusable
XCALIBER META-DIAPHYSEAL/ANKLE INSTRUMENTS STERIBOX, EMPTY
ORTHOFIX SRL
1
In Commercial Distribution

  • 18032568867282 ()
91990

  • Instrument tray, reusable
XCALIBER ARTICULATED ANKLE KIT WITH DYNAMIC C/D UNIT STERILE
ORTHOFIX SRL
1
In Commercial Distribution

  • 18032568867213 ()
99-91245

  • External orthopaedic fixation system, single-use
XCALIBER META-DIAPHYSEAL KIT WITH DYNAMIC C/D UNIT STERILE
ORTHOFIX SRL
1
In Commercial Distribution

  • 18032568867206 ()
99-91215

  • External orthopaedic fixation system, single-use
XCALIBER HYBRID KIT STERILE
ORTHOFIX SRL
1
In Commercial Distribution

  • 18032568863352 ()
99-91080

  • External orthopaedic fixation system, single-use
XCALIBER ARTICULATED ANKLE KIT STERILE
ORTHOFIX SRL
1
In Commercial Distribution

  • 18032568863345 ()
99-91047

  • External orthopaedic fixation system, single-use
SUPPLEMENTARY SCREW HOLDER (BARS AND CLAMPS) STERILE
ORTHOFIX SRL
1
In Commercial Distribution

  • 18032568863338 ()
99-91038

  • External orthopaedic fixation system, single-use
XCALIBER DYNAMIC C/D UNIT STERILE
ORTHOFIX SRL
1
In Commercial Distribution

  • 18032568863321 ()
99-91015

  • External orthopaedic fixation system, single-use
XCALIBER META-DIAPHYSEAL KIT STERILE
ORTHOFIX SRL
1
In Commercial Distribution

  • 18032568863307 ()
99-91000

  • External orthopaedic fixation system, single-use
PRECICE ERC 3P Shipping Pkg US
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
ERC 3P
In Commercial Distribution

  • 00887517001344 ()

  • Tool/Instrument
EAD-P3-010

  • Distraction implant adjustment remote control
XCALIBER MANIPULATION FORCEPS
ORTHOFIX SRL
1
In Commercial Distribution

  • 18032568035216 ()
19200

  • External orthopaedic fixation system, reusable
PRECICE ERC 4P Shipping Pkg US
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
ERC 4P
In Commercial Distribution

  • 00887517014979 ()

  • Tool/Instrument
EAD-P4-010

  • Distraction implant adjustment remote control
RADIOLUCENT ANKLE PIN GUIDE STERILE
ORTHOFIX SRL
1
In Commercial Distribution

  • 18032568861617 ()
99-11947

  • External orthopaedic fixation system, single-use
UNIVERSAL ALLEN WRENCH
ORTHOFIX SRL
1
In Commercial Distribution

  • 18032568861341 ()
91017

  • Surgical torque wrench, reusable
SUPPLEMENTARY SCREW HOLDER
ORTHOFIX SRL
1
In Commercial Distribution

  • 18032568861259 ()
90037

  • External orthopaedic fixation system, reusable
RAIL DISTRACTOR LOW PROFILE RIGHT
Smith & Nephew, Inc.
71934149
Not in Commercial Distribution

  • 00885556534038 ()
71934149

  • External orthopaedic fixation system, single-use
1 HOLE 3 DEGREE RANCHO CUBE
Smith & Nephew, Inc.
71932452
In Commercial Distribution

  • 00885556057414 ()
71932452

  • External orthopaedic fixation system, single-use
FOCAL DOME OSTEOTOMY GUIDE ASSEMBLY
Smith & Nephew, Inc.
71929621
In Commercial Distribution

  • 00885556049839 ()
71929621

  • Orthopaedic osteotome
4 HOLE CUBE W/THREADED END
Smith & Nephew, Inc.
71929495
In Commercial Distribution

  • 00885556048719 ()
71929495

  • External orthopaedic fixation system, reusable
17 DEGREE WEDGE
Smith & Nephew, Inc.
71929494
Not in Commercial Distribution

  • 00885556048573 ()
71929494

  • External orthopaedic fixation system, reusable
TRACTION PIN W/TROCAR POINT BOTH ENDS 5/64X9.0
Smith & Nephew, Inc.
71927392
Not in Commercial Distribution

  • 00885556045602 ()
71927392

  • External orthopaedic fixation system, single-use
HEX FIX SWIVEL ADAPTER
Smith & Nephew, Inc.
71925829
Not in Commercial Distribution

  • 00885556045015 ()
71925829

  • General internal orthopaedic fixation system implantation kit
INSTRUMENT CASE
Smith & Nephew, Inc.
71061010
In Commercial Distribution

  • 00885556119686 ()
71061010

  • Instrument tray, reusable
COMPASS KNEE KIT
Smith & Nephew, Inc.
71061016
In Commercial Distribution

  • 00885556012338 ()
71061016

  • Instrument tray, reusable
COMPASS KNEE ALIGNMENT GUIDE
Smith & Nephew, Inc.
71061011
In Commercial Distribution

  • 20885556012264 ()
  • 00885556012260 ()
71061011

  • External orthopaedic fixation system, reusable
5MM X 25MM ARROW HALF PIN - STAINLESS STEEL
Smith & Nephew, Inc.
71055025
In Commercial Distribution

  • 00885556012161 ()
71055025

  • External orthopaedic fixation system, single-use
4.8MM DRILL BIT
Smith & Nephew, Inc.
71053004
In Commercial Distribution

  • 00885556012116 ()
71053004

  • Surgical drill guide, reusable
3.2MM X 86MM TROCAR PIN
Smith & Nephew, Inc.
71061001
In Commercial Distribution

  • 20885556012066 ()
  • 00885556012062 ()
71061001

  • Orthopaedic trocar blade, single-use
2.8MM DRILL BIT
Smith & Nephew, Inc.
71053002
In Commercial Distribution

  • 00885556011997 ()
71053002

  • Surgical drill guide, reusable
DISC CLIPS
Smith & Nephew, Inc.
71061013
In Commercial Distribution

  • 00885556011744 ()
71061013

  • External orthopaedic fixation system, single-use
COMPASS KNEE ALIGNMENT STAND
Smith & Nephew, Inc.
71061012
In Commercial Distribution

  • 20885556011434 ()
  • 00885556011430 ()
71061012

  • External orthopaedic fixation system, reusable
LARGE-STANDARD COMPRESSION/DISTRACTION MODULE
Smith & Nephew, Inc.
71051012
In Commercial Distribution

  • 00885556011089 ()
71051012

  • External orthopaedic fixation system, single-use
CROSS PIN
Smith & Nephew, Inc.
110732
In Commercial Distribution

  • 00885556007303 ()
110732

  • General internal orthopaedic fixation system implantation kit
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