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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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EnSite™ - 05415067051257

X EP System Display Workstation
ST. JUDE MEDICAL, INC.
ENSITE-DWS-04
In Commercial Distribution

  • 05415067051257 ()
ENSITE-DWS-04

  • Cardiac mapping system

EnSite™ - 05415067051226

X EP System Display Workstation
ST. JUDE MEDICAL, INC.
ENSITE-R-DWS-04
In Commercial Distribution

  • 05415067051226 ()
ENSITE-R-DWS-04

  • Cardiac mapping system

Welch Allyn, Inc. - 00732094231014

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

  • 00732094231014 ()
  • 00732094118865 ()
85MXVX

  • Multiple vital physiological parameter monitoring system, clinical

Welch Allyn, Inc. - 00732094230901

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

  • 00732094230901 ()
  • 00732094058086 ()
84MXVE

  • Multiple vital physiological parameter monitoring system, clinical

Welch Allyn, Inc. - 00732094230888

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

  • 00732094230888 ()
  • 00732094057485 ()
84NXVE

  • Multiple vital physiological parameter monitoring system, clinical

Welch Allyn, Inc. - 00732094230857

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

  • 00732094230857 ()
  • 00732094118803 ()
85NXVX

  • 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
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