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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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OptiMap Monitor - 00850064686029

OptiMap Monitor
Cortex, Inc.
FG0009
In Commercial Distribution

  • 00850064686029 ()
OPTI-MON

  • Cardiac mapping system

OptiMap™ Workstation - 00850064686012

OptiMap Workstation
Cortex, Inc.
FG0008
In Commercial Distribution

  • 00850064686012 ()
OPTI-WS

  • Cardiac mapping system

Welch Allyn, Inc. - 00732094230871

CIWS STD NEL SCS
WELCH ALLYN, INC.
901028
In Commercial Distribution

  • 00732094230871 ()
  • 00732094119312 ()
84NXVX

  • Multiple vital physiological parameter monitoring system, clinical

Welch Allyn, Inc. - 00732094230826

CIWS WRLS NEL SCS IRT
WELCH ALLYN, INC.
901028
In Commercial Distribution

  • 00732094230826 ()
  • 00732094055054 ()
85NXVE

  • Multiple vital physiological parameter monitoring system, clinical

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

Axiom - 00840363369037

4 x 5 Lateral Pads, Curved with Adj. S/A Mounting Hardware for BTX Right
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363369037 ()

  • Length: 4 Inch
  • Width: 5 Inch
PLLASC4x5BR

  • Wheelchair head/trunk support, prefabricated

Axiom - 00840363369020

3 x 4 Lateral Pads, Curved with Adj. S/A Mounting Hardware for BTX Right
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363369020 ()

  • Length: 3 Inch
  • Width: 4 Inch
PLLASC3x4BR

  • Wheelchair head/trunk support, prefabricated

Axiom - 00840363369013

4 x 5 Lateral Pads, Flat with Adj. S/A Mounting Hardware for BTX Right
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363369013 ()

  • Length: 4 Inch
  • Width: 5 Inch
PLLAS4x5BR

  • Wheelchair head/trunk support, prefabricated

Axiom - 00840363368931

4 x 5 Lateral Pads, Curved with Adj. S/A Mounting Hardware for BTX Left
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363368931 ()

  • Length: 4 Inch
  • Width: 5 Inch
PLLASC4x5BL

  • Wheelchair head/trunk support, prefabricated

Axiom - 00840363368917

4 x 5 Lateral Pads, Flat with Adj. S/A Mounting Hardware for BTX Left
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363368917 ()

  • Length: 4 Inch
  • Width: 5 Inch
PLLAS4x5BL

  • Wheelchair head/trunk support, prefabricated
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