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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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CRANIOFIX2 - 04038653379576

CRANIOFIX 2 TITANIUM CLAMP 11MM
Aesculap AG
FF490T
In Commercial Distribution

  • 04038653379576 ()
  • 04038653379569 ()
FF490T

  • Craniofacial fixation plate, non-bioabsorbable, non-customized

AESCULAP - 04038653377794

Mallet, 9" (230 mm), diam. 11,50 mm, 20 mm, peek handle, stainless steel, 432 g, 180 g
Aesculap AG
FL072K
In Commercial Distribution

  • 04038653377794 ()
FL072K

  • Surgical mallet

VERTU - 00840606139304

FIXED ANGLE BREAKAWAY DRIVER
SPINAL ELEMENTS, INC.
53025-000
In Commercial Distribution

  • 00840606139304 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

ANAX™ 5.5 SPINAL SYSTEM - 08800037510648

No Description
CG MedTech Co.,Ltd.
SFD0060
In Commercial Distribution

  • 08800037510648 ()


  • Orthopaedic implant driver

ASPIRON™ ACP SYSTEM - 08800037509697

No Description
CG MedTech Co.,Ltd.
NCS1030
In Commercial Distribution

  • 08800037509697 ()


  • Orthopaedic implant driver

Velofix™ SA Cervical Cage - 08800037509598

No Description
CG MedTech Co.,Ltd.
TS0170
In Commercial Distribution

  • 08800037509598 ()


  • Orthopaedic implant driver

SAPPHIRE - 00840606136303

SAPPHIRE® BREAKAWAY DRIVER
SPINAL ELEMENTS, INC.
26115-000
In Commercial Distribution

  • 00840606136303 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

MAGNUM+ - 00840606132145

MAGNUM+® LOW PROFILE BREAKAWAY DRIVER
SPINAL ELEMENTS, INC.
15123-000
In Commercial Distribution

  • 00840606132145 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

MAGNUM+ - 00840606132138

MAGNUM+® COUNTER TORQUE BREAKAWAY DRIVER
SPINAL ELEMENTS, INC.
15122-000
In Commercial Distribution

  • 00840606132138 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

MAGNUM+ - 00840606132060

MAGNUM+® FIXED ANGLE BREAKAWAY DRIVER
SPINAL ELEMENTS, INC.
15119-000
In Commercial Distribution

  • 00840606132060 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

MAGNUM+ - 00840606132053

MAGNUM+® FIXED ANGLE BREAKAWAY DRIVER FLEX SHAFT ASSEMBLY
SPINAL ELEMENTS, INC.
15118-000-13
In Commercial Distribution

  • 00840606132053 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

MAGNUM+ - 00840606132046

MAGNUM+® FIXED ANGLE BREAKAWAY DRIVER
SPINAL ELEMENTS, INC.
15118-000
In Commercial Distribution

  • 00840606132046 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

MAGNUM+ - 00840606132039

MAGNUM+® FLEXIBLE BREAKAWAY DRIVER
SPINAL ELEMENTS, INC.
15117-000
In Commercial Distribution

  • 00840606132039 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

MAGNUM+ - 00840606132022

MAGNUM+® BREAKAWAY DRIVER
SPINAL ELEMENTS, INC.
15115-000
In Commercial Distribution

  • 00840606132022 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

MAGNUM+ - 00840606131988

60° FIXED ANGLE DRIVER
SPINAL ELEMENTS, INC.
15109-060
In Commercial Distribution

  • 00840606131988 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

MAGNUM+ - 00840606131971

MAGNUM+® WELDED ANGLED TUBE, FIXED ANGLE LINK DRIVER
SPINAL ELEMENTS, INC.
15109-045-04
In Commercial Distribution

  • 00840606131971 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

MAGNUM+ - 00840606131964

45° FIXED ANGLE DRIVER
SPINAL ELEMENTS, INC.
15109-045
In Commercial Distribution

  • 00840606131964 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

MAGNUM+ - 00840606131957

MAGNUM+® WELDED ANGLED TUBE, FIXED ANGLE LINK DRIVER
SPINAL ELEMENTS, INC.
15109-030-04
In Commercial Distribution

  • 00840606131957 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

MAGNUM+ - 00840606131940

30° FIXED ANGLE DRIVER
SPINAL ELEMENTS, INC.
15109-030
In Commercial Distribution

  • 00840606131940 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

MAGNUM+ - 00840606131926

FIXED ANGLE BONE SCREW DRIVER
SPINAL ELEMENTS, INC.
15106-000
In Commercial Distribution

  • 00840606131926 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

MAGNUM+ - 00840606131919

FLEXIBLE BONE SCREW DRIVER SHAFT
SPINAL ELEMENTS, INC.
15105-004
In Commercial Distribution

  • 00840606131919 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

MAGNUM+ - 00840606131865

MODULAR BONE SCREW DRIVER TIP, 3.0MM LONG
SPINAL ELEMENTS, INC.
15104-000
In Commercial Distribution

  • 00840606131865 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

MAGNUM+ - 00840606131858

MODULAR BONE SCREW DRIVER TIP
SPINAL ELEMENTS, INC.
15103-000
In Commercial Distribution

  • 00840606131858 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

MAGNUM+ - 00840606131841

FLEXIBLE BONE SCREW DRIVER
SPINAL ELEMENTS, INC.
15102-000
In Commercial Distribution

  • 00840606131841 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

MAGNUM+ - 00840606131834

BONE SCREW DRIVER, 3.0 MM LONG
SPINAL ELEMENTS, INC.
15101-000
In Commercial Distribution

  • 00840606131834 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

MAGNUM+ - 00840606131827

BONE SCREW DRIVER
SPINAL ELEMENTS, INC.
15100-000
In Commercial Distribution

  • 00840606131827 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

DynaLink - 00190837104627

3.5mm Ball End Hex Driver
Life Spine, Inc.
125-699
In Commercial Distribution

  • 00190837104627 ()
125-699

  • Polymeric spinal interbody fusion cage

DynaLink - 00190837104559

4mm Hex Driver
Life Spine, Inc.
125-704
In Commercial Distribution

  • 00190837104559 ()
125-704

  • Polymeric spinal interbody fusion cage

Longbow Ti - 00190837095475

1/4 Square Driver, 5mm Hex
Life Spine, Inc.
149-424
In Commercial Distribution

  • 00190837095475 ()
149-424

  • Interspinous spinal fixation implant

AESCULAP - 04038653403400

S4 SCREW DRIVER F/MONOAXIAL SCREWS
Aesculap AG
FW176R
In Commercial Distribution

  • 04038653403400 ()
FW176R

  • Orthopaedic prosthesis implantation positioning instrument, reusable

TARGON - 04038653402885

TARGON SCREW DRIVER SW4.5 W/HEXAG.SHANK
Aesculap AG
KH289R
Not in Commercial Distribution

  • 04038653402885 ()
KH289R

  • Orthopaedic prosthesis implantation positioning instrument, reusable

CRANIOFIX2 - 04038653402243

CRANIOFIX 2 TITANIUM CLAMP 20MM
Aesculap AG
FF492T
In Commercial Distribution

  • 04038653402243 ()
  • 04038653379606 ()
FF492T

  • Craniofacial fixation plate, non-bioabsorbable, non-customized

AESCULAP - 04038653400515

S4 SCREW DRIVER W/SHANK TIP
Aesculap AG
FW174R
In Commercial Distribution

  • 04038653400515 ()
FW174R

  • Orthopaedic prosthesis implantation positioning instrument, reusable

ABC - 04038653397006

ABC SCREW DRIVER
Aesculap AG
FJ845R
In Commercial Distribution

  • 04038653397006 ()
FJ845R

  • Orthopaedic prosthesis implantation positioning instrument, reusable

Velofix™ SA Cervical Cage - 08800037521224

No Description
CG MedTech Co.,Ltd.
TS0070
In Commercial Distribution

  • 08800037521224 ()


  • Orthopaedic implant driver

Perfix™ Spinal System - 08800037521163

No Description
CG MedTech Co.,Ltd.
SNS0023
In Commercial Distribution

  • 08800037521163 ()


  • Surgical screwdriver, reusable

ASPIRON™ S ACP SYSTEM - 08800037521002

No Description
CG MedTech Co.,Ltd.
FC7150
In Commercial Distribution

  • 08800037521002 ()


  • Surgical screwdriver, reusable

ANAX™ OCT SPINAL SYSTEM - 08800037520982

No Description
CG MedTech Co.,Ltd.
OS0150
In Commercial Distribution

  • 08800037520982 ()


  • Surgical screwdriver, reusable

AESCULAP - 04038653392612

SCREW DRIVER BIT TORX T20 / AF3.5
Aesculap AG
NE358R
In Commercial Distribution

  • 04038653392612 ()
NE358R

  • Orthopaedic prosthesis implantation positioning instrument, reusable

CRANIOFIX2 - 04038653379583

CRANIOFIX 2 TITANIUM CLAMP 16MM
Aesculap AG
FF491T
In Commercial Distribution

  • 04038653379583 ()
  • 04038653379590 ()
FF491T

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
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