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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3.5 SCREW 35mm
Orthopediatrics Canada ULC
GRO-CS35-35
In Commercial Distribution

  • 07540194017031 ()

  • Length: 35 Millimeter
GRO-CS35-35

  • Orthopaedic bone screw (non-sliding)
3.5 SCREW 30mm
Orthopediatrics Canada ULC
GRO-CS35-30
In Commercial Distribution

  • 07540194017024 ()

  • Length: 30 Millimeter
GRO-CS35-30

  • Orthopaedic bone screw (non-sliding)
3.5 SCREW 20mm
Orthopediatrics Canada ULC
GRO-CS35-20
In Commercial Distribution

  • 07540194017000 ()

  • Length: 20 Millimeter
GRO-CS35-20

  • Orthopaedic bone screw (non-sliding)
3.5 SCREW 15mm
Orthopediatrics Canada ULC
GRO-CS35-15
In Commercial Distribution

  • 07540194016997 ()

  • Length: 15 Millimeter
GRO-CS35-15

  • Orthopaedic bone screw (non-sliding)
HEX CANNULATED DRIVER SHAFT 3.5mm
Orthopediatrics Canada ULC
GRO-CDS235
In Commercial Distribution

  • 07540194016980 ()
GRO-CDS235

  • Surgical screwdriver, reusable
HEX CANNULATED DRIVER 3.5mm
Orthopediatrics Canada ULC
GRO-CDR235
In Commercial Distribution

  • 07540194016973 ()
GRO-CDR235

  • Surgical screwdriver, reusable
ADJUSTABLE GIRO DISTRACTOR
Orthopediatrics Canada ULC
GRO-AGD200
In Commercial Distribution

  • 07540194016966 ()
GRO-AGD200

  • Orthopaedic prosthesis implantation positioning instrument, reusable
6.0 GIRO 14mm
Orthopediatrics Canada ULC
GRO-A60-014
In Commercial Distribution

  • 07540194016959 ()

  • Length: 14 Millimeter
GRO-A60-014

  • Orthopaedic fixation plate, non-bioabsorbable
4.5 GIRO 14mm
Orthopediatrics Canada ULC
GRO-A45-014
In Commercial Distribution

  • 07540194016942 ()

  • Length: 14 Millimeter
GRO-A45-014

  • Orthopaedic fixation plate, non-bioabsorbable
GAP 2.0 FULL INSTRUMENTS CASE
Orthopediatrics Canada ULC
GAP-INF200
In Commercial Distribution

  • 07540194016904 ()
GAP-INF200

  • General internal orthopaedic fixation system implantation kit
GAP 2.0 EMPTY INSTRUMENTS CASE
Orthopediatrics Canada ULC
GAP-INE200
In Commercial Distribution

  • 07540194016898 ()

  • Length: 150 Millimeter
  • Outer Diameter: 2.75 Millimeter
GAP-INE200

  • Surgical instrument/implant rack
GAP 2.0 FULL IMPLANT CASE 2 - COMPONENTS
Orthopediatrics Canada ULC
GAP-IMF250
In Commercial Distribution

  • 07540194016874 ()
GAP-IMF250

  • Arthrodesis intramedullary nail, non-distracting
GAP 2.0 FULL IMPLANT CASE 1 - NAIL
Orthopediatrics Canada ULC
GAP-IMF200
In Commercial Distribution

  • 07540194016843 ()
GAP-IMF200

  • Arthrodesis intramedullary nail, non-distracting
GAP 2.0 LAG THREAD CUTTER
Orthopediatrics Canada ULC
GAP-LGC200
In Commercial Distribution

  • 07540194016805 ()
GAP-LGC200

  • Orthopaedic implantable-device cutter
GAP 2.0 RESCUE NAIL DRIVER
Orthopediatrics Canada ULC
GAP-RSC200
In Commercial Distribution

  • 07540194016799 ()
GAP-RSC200

  • Orthopaedic implant driver
GAP 2.0 NAIL DRIVER ADAPTER
Orthopediatrics Canada ULC
GAP-NDA220
In Commercial Distribution

  • 07540194016775 ()
GAP-NDA220

  • Orthopaedic prosthesis implantation positioning instrument, reusable
GAP 2.0 CORTICAL SCREW SLEEVE
Orthopediatrics Canada ULC
GAP-SCS200
In Commercial Distribution

  • 07540194016768 ()
GAP-SCS200

  • Surgical drill guide, reusable
GAP 2.0 CORTICAL SCREW DRILL Ø4mm
Orthopediatrics Canada ULC
GAP-DCS204
In Commercial Distribution

  • 07540194016751 ()

  • Outer Diameter: 4 Millimeter
GAP-DCS204

  • Fluted surgical drill bit, reusable
GAP 2.0 CANAL REAMER Ø4.8mm
Orthopediatrics Canada ULC
GAP-DCA248
In Commercial Distribution

  • 07540194016744 ()

  • Outer Diameter: 4.8 Millimeter
GAP-DCA248

  • Cannulated surgical drill bit, reusable
GAP 2.0 LAG RULER SLEEVE
Orthopediatrics Canada ULC
GAP-SDG200
In Commercial Distribution

  • 07540194016737 ()
GAP-SDG200

  • Orthopaedic prosthesis implantation positioning instrument, reusable
GAP 2.0 NAIL DRIVER
Orthopediatrics Canada ULC
GAP-NDR200
In Commercial Distribution

  • 07540194016720 ()
GAP-NDR200

  • Orthopaedic implant driver
GAP 2.0 SHORT 2.5mm HEX SCREWDRIVER SHAFT
Orthopediatrics Canada ULC
GAP-SMP200
In Commercial Distribution

  • 07540194016713 ()
GAP-SMP200

  • Surgical screwdriver, reusable
GAP 2.0 MECHANICAL SCREW SLEEVE
Orthopediatrics Canada ULC
GAP-SMS200
In Commercial Distribution

  • 07540194016706 ()
GAP-SMS200

  • Surgical drill guide, reusable
GAP 2.0 TARGETING DEVICE
Orthopediatrics Canada ULC
GAP-TGD200
In Commercial Distribution

  • 07540194016690 ()
GAP-TGD200

  • Orthopaedic prosthesis implantation positioning instrument, reusable
GAP 2.0 CONICAL REAMER
Orthopediatrics Canada ULC
GAP-DTP200
In Commercial Distribution

  • 07540194016683 ()
GAP-DTP200

  • Cannulated surgical drill bit, reusable
GAP 2.0 CANAL REAMER Ø8.0mm
Orthopediatrics Canada ULC
GAP-DCA280
In Commercial Distribution

  • 07540194016676 ()

  • Outer Diameter: 8.0 Millimeter
GAP-DCA280

  • Cannulated surgical drill bit, reusable
GAP 2.0 LAG SCREW SLEEVE
Orthopediatrics Canada ULC
GAP-SLS200
In Commercial Distribution

  • 07540194016669 ()
GAP-SLS200

  • Surgical drill guide, reusable
GAP 2.0 CORTICAL SCREW DRILL Ø3mm
Orthopediatrics Canada ULC
GAP-DCS203
In Commercial Distribution

  • 07540194016652 ()

  • Outer Diameter: 3 Millimeter
GAP-DCS203

  • Fluted surgical drill bit, reusable
GAP 2.0 DEPTH GAGE
Orthopediatrics Canada ULC
GAP-DPG250
In Commercial Distribution

  • 07540194016645 ()
GAP-DPG250

  • Surgical depth gauge, reusable
GAP 2.0 MECHANICAL SCREW DRILL
Orthopediatrics Canada ULC
GAP-DMS200
In Commercial Distribution

  • 07540194016638 ()
GAP-DMS200

  • Fluted surgical drill bit, reusable
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