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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FULL 2.0mm PEG CADDY
Orthopediatrics Canada ULC
PEG-CFL-20
In Commercial Distribution

  • 07540194012050 ()
PEG-CFL-20

  • Orthopaedic bone screw (non-sliding)
EMPTY 2.8mm PEG CADDY
Orthopediatrics Canada ULC
PEG-CEM-28
In Commercial Distribution

  • 07540194012043 ()
PEG-CEM-28

  • Surgical instrument/implant rack
EMPTY 2.4mm PEG CADDY
Orthopediatrics Canada ULC
PEG-CEM-24
In Commercial Distribution

  • 07540194012036 ()
PEG-CEM-24

  • Instrument tray, reusable
EMPTY 2.0mm PEG CADDY
Orthopediatrics Canada ULC
PEG-CEM-20
In Commercial Distribution

  • 07540194012029 ()
PEG-CEM-20

  • Instrument tray, reusable
AO HANDLE
Orthopediatrics Canada ULC
GIN-AOH100
In Commercial Distribution

  • 07540194012012 ()
GIN-AOH100

  • Surgical instrument handle, non-torque-limiting
REAMER Ø2.6mm
Orthopediatrics Canada ULC
GIN-DCA026
In Commercial Distribution

  • 07540194012005 ()

  • Length: 330 Millimeter
  • Outer Diameter: 2.7 Millimeter
GIN-DCA026

  • Fluted surgical drill bit, reusable
TISSUE PROTECTOR
Orthopediatrics Canada ULC
GIN-TPR100
In Commercial Distribution

  • 07540194011992 ()
GIN-TPR100

  • Surgical drill guide, reusable
EMPTY PEG IMPLANT & INSTRUMENT CASE
Orthopediatrics Canada ULC
PEG-CSE100
In Commercial Distribution

  • 07540194011978 ()
PEG-CSE100

  • Surgical instrument/implant rack
FULL HP SCREW CADDY
Orthopediatrics Canada ULC
HP-CYF150
In Commercial Distribution

  • 07540194011961 ()
HP-CYF150

  • Orthopaedic fixation plate, non-bioabsorbable
EMPTY HP SCREW CADDY
Orthopediatrics Canada ULC
HP-CYE100
In Commercial Distribution

  • 07540194011954 ()
HP-CYE100

  • Surgical instrument/implant rack
EMPTY SLIM CAP CADDY
Orthopediatrics Canada ULC
SLM-CYE125
In Commercial Distribution

  • 07540194011947 ()
SLM-CYE125

  • Surgical instrument/implant rack
BULLET GUIDEWIRE Ø2.0mm - PACKAGE OF 6
Orthopediatrics Canada ULC
BLT-GWR200-PKG6
In Commercial Distribution

  • 07540194012746 ()
  • 07540194011930 ()

  • Outer Diameter: 2 Millimeter
BLT-GWR200-PKG6

  • Orthopaedic guidewire, single-use
BULLET GUIDEWIRE Ø1.1mm - PACKAGE OF 6
Orthopediatrics Canada ULC
BLT-GWR100-PKG6
In Commercial Distribution

  • 07540194012739 ()
  • 07540194011923 ()

  • Outer Diameter: 1.1 Millimeter
BLT-GWR100-PKG6

  • Orthopaedic guidewire, single-use
EMPTY BULLET IMPLANT & INSTRUMENT CASE
Orthopediatrics Canada ULC
BLT-CSE100
In Commercial Distribution

  • 07540194011787 ()
BLT-CSE100

  • Surgical instrument/implant rack
PEG DRILL 2.8 mm
Orthopediatrics Canada ULC
PEG-PGD128
In Commercial Distribution

  • 07540194011770 ()

  • Outer Diameter: 2.75 Millimeter
  • Length: 150 Millimeter
PEG-PGD128

  • Fluted surgical drill bit, reusable
PEG DRILL 2.4 mm
Orthopediatrics Canada ULC
PEG-PGD124
In Commercial Distribution

  • 07540194011763 ()

  • Length: 150 Millimeter
  • Outer Diameter: 2.35 Millimeter
PEG-PGD124

  • Fluted surgical drill bit, reusable
PEG DRILL 2.0 mm
Orthopediatrics Canada ULC
PEG-PGD120
In Commercial Distribution

  • 07540194011756 ()

  • Outer Diameter: 1.95 Millimeter
  • Length: 150 Millimeter
PEG-PGD120

  • Fluted surgical drill bit, reusable
T8 TORX SCREWDRIVER
Orthopediatrics Canada ULC
GIN-TRX800
In Commercial Distribution

  • 07540194011749 ()
GIN-TRX800

  • Surgical screwdriver, reusable
T6 TORX SCREWDRIVER
Orthopediatrics Canada ULC
GIN-TRX600
In Commercial Distribution

  • 07540194011732 ()
GIN-TRX600

  • Surgical screwdriver, reusable
A-O HANDLE - BULLET
Orthopediatrics Canada ULC
BLT-AOH100
In Commercial Distribution

  • 07540194011725 ()
BLT-AOH100

  • Surgical instrument handle, torque-limiting
BULLET RETENTION SLEEVE
Orthopediatrics Canada ULC
BLT-RSH100
In Commercial Distribution

  • 07540194011718 ()
BLT-RSH100

  • Surgical drill guide, reusable
BULLET GUIDEWIRE SLEEVE
Orthopediatrics Canada ULC
BLT-GWS100
In Commercial Distribution

  • 07540194011701 ()
BLT-GWS100

  • Orthopaedic prosthesis implantation positioning instrument, reusable
BULLET GUIDEWIRE Ø2.0mm x 305mm
Orthopediatrics Canada ULC
BLT-GWR200
In Commercial Distribution

  • 07540194011695 ()

  • Outer Diameter: 2 Millimeter
BLT-GWR200

  • Orthopaedic guidewire, single-use
BULLET GUIDEWIRE Ø1.1mm x 305mm
Orthopediatrics Canada ULC
BLT-GWR100
In Commercial Distribution

  • 07540194011688 ()

  • Outer Diameter: 1.1 Millimeter
BLT-GWR100

  • Orthopaedic guidewire, single-use
T-HANDLE
Orthopediatrics Canada ULC
BLT-AXH100
In Commercial Distribution

  • 07540194011671 ()
BLT-AXH100

  • Surgical instrument handle, non-torque-limiting
BULLET DRILL 6.0mm
Orthopediatrics Canada ULC
BLT-BDR160
In Commercial Distribution

  • 07540194011664 ()

  • Length: 175 Millimeter
  • Outer Diameter: 6.1 Millimeter
BLT-BDR160

  • Cannulated surgical drill bit, reusable
PEG Ø2.4mm x 60mm
Orthopediatrics Canada ULC
FD-PEG-24-060
In Commercial Distribution

  • 07540194017888 ()

  • Outer Diameter: 2.4 Millimeter
  • Length: 60 Millimeter
FD-PEG-24-060

  • Orthopaedic bone screw (non-sliding)
PEG Ø2.4mm x 56mm
Orthopediatrics Canada ULC
FD-PEG-24-056
In Commercial Distribution

  • 07540194017871 ()

  • Outer Diameter: 2.4 Millimeter
  • Length: 56 Millimeter
FD-PEG-24-056

  • Orthopaedic bone screw (non-sliding)
PEG Ø2.4mm x 52mm
Orthopediatrics Canada ULC
FD-PEG-24-052
In Commercial Distribution

  • 07540194017864 ()

  • Length: 52 Millimeter
  • Outer Diameter: 2.4 Millimeter
FD-PEG-24-052

  • Orthopaedic bone screw (non-sliding)
PEG Ø2.4mm x 48mm
Orthopediatrics Canada ULC
FD-PEG-24-048
In Commercial Distribution

  • 07540194017857 ()

  • Length: 48 Millimeter
  • Outer Diameter: 2.4 Millimeter
FD-PEG-24-048

  • Orthopaedic bone screw (non-sliding)
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