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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 Class Implantable

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External Fixation - 00190837033897

Hardware Caddy
Life Spine, Inc.
114-385
In Commercial Distribution

  • 00190837033897 ()
114-385

  • External orthopaedic fixation system, single-use

Revolution External Plating System - 00854641008082

Instrument + Hardware Tray
Metalogix
900126-F
In Commercial Distribution

  • 00854641008082 ()

  • Height: 5.5 Inch
  • Length: 20.9 Inch
  • Width: 10.3 Inch


  • External orthopaedic fixation system, reusable

PMT® CORPORATION HALO - 00650551045830

TRACTION BAIL WITH HEADBLOCK ATTACHMENT HARDWARE
PMT CORPORATION
1206-13
In Commercial Distribution

  • 00650551045830 ()
1206-13

  • Cervical spine immobilization system, single-use

PMT® CORPORATION HALO - 00650551044895

SHOULDER STRAP ASSEMBLY, INCLUDES: PLASTIC TAB, STRAP, HARDWARE
PMT CORPORATION
1201-48
In Commercial Distribution

  • 00650551044895 ()
1201-48

  • Cervical spine immobilization system, single-use

PMT® CORPORATION HALO - 00650551044888

VEST WAIST STRAP ASSEMBLY, INCLUDES: BUCKLE BLOCK, PLASTIC TAB, STRAP, HARDWARE
PMT CORPORATION
1201-46
In Commercial Distribution

  • 00650551044888 ()
1201-46

  • Cervical spine immobilization system, single-use

PMT CORPORATION HALO - 00650551141686

TRACTION BAIL HARDWARE - (2) 3/4" SHCS, (2) WASHERS, (1) ALLEN WRENCH
PMT CORPORATION
1206-17
In Commercial Distribution

  • 00650551141686 ()
1206-17

  • Cervical spine immobilization system, single-use

PMT® CORPORATION HALO - 00650551044840

HEAD BLOCK ATTACH HARDWARE SET: (4) SOCKET HEAD CAP SCREWS, (4) WASHERS, (2) ALLEN WRENCHES
PMT CORPORATION
1201-36
In Commercial Distribution

  • 00650551044840 ()
1201-36

  • Cervical spine immobilization system, single-use

HALO SYSTEM COMPONENT - 00650551098393

RING/BLOCK ATTACH HARDWARE SET: (4) SHCS, (4)WASHER, (1)ALLEN WRENCH FOR CLOSED BACK RINGS
PMT CORPORATION
1201-37
In Commercial Distribution

  • 00650551098393 ()


  • Cervical spine immobilization system, single-use

External Fixator Pin cluster clamp 15 Stainless steel hardware - 07640136270019

Element intended to become part of an assembly of non-sterile devices designed to stabilize fractured bones to promote treatment and healing. It typically consists of an external plastic and/or metallic fixator (a framework) and other external and/or implantable components such as clamps, rods, rings, pins, bolts, and nuts, as well as some reusable instrumentation (e.g., wrenches, depth gauge, tensioner). It is used mainly to help the healing of long bones such as the femur, tibia and humerus, as well as fractures of the foot and ankle, joint fusions, and limb lengthening. This is a single-use device intended to be sterilized prior to use.
GEXFIX SA
1010-1010
In Commercial Distribution

  • 07640136270019 ()


  • External orthopaedic fixation system, single-use

Penumbra Coil 400 - 00815948025103

Coil 400 Standard, 15mm x 45cm
PENUMBRA, INC.
4002C1545-A
In Commercial Distribution

  • 00815948025103 ()
4002C1545

  • Neurovascular embolization coil
  • Surgical microscope video camera, sterilizable
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