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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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CD HORIZON Spinal System - 00643169576759

TAP 6641050 5.0MM CANNULATED DUAL LEAD
MEDTRONIC SOFAMOR DANEK, INC.
6641050
In Commercial Distribution

  • 00643169576759 ()

  • Outer Diameter: 5.0 Millimeter


  • Fluted surgical drill bit, reusable

CD HORIZON Spinal System - 00643169576742

TAP 6641045 4.5MM CANNULATED DUAL LEAD
MEDTRONIC SOFAMOR DANEK, INC.
6641045
In Commercial Distribution

  • 00643169576742 ()

  • Outer Diameter: 4.5 Millimeter


  • Fluted surgical drill bit, reusable

CD HORIZON Spinal System - 00643169576735

TAP 6641040 4.0MM CANNULATED DUAL LEAD
MEDTRONIC SOFAMOR DANEK, INC.
6641040
In Commercial Distribution

  • 00643169576735 ()

  • Outer Diameter: 4.0 Millimeter


  • Fluted surgical drill bit, reusable

CD HORIZON Spinal System - 00643169576728

TAP 6641010 10.0MM CANN DUAL LEAD
MEDTRONIC SOFAMOR DANEK, INC.
6641010
In Commercial Distribution

  • 00643169576728 ()

  • Outer Diameter: 10.0 Millimeter


  • Fluted surgical drill bit, reusable

CD HORIZON Spinal System - 00643169576629

ROTATOR 6640018 ROD ROTATOR
MEDTRONIC SOFAMOR DANEK, INC.
6640018
In Commercial Distribution

  • 00643169576629 ()


  • Surgical implant/trial-implant/sizer holder, reusable

Rotaflow Pack CD Softline - 00607567211490

Softshell Venous Reser. 1900ml w. connector 700000292, BO-RF32 RotaFlow, Gas Filter
DATASCOPE CORP.
BO-T 39705
In Commercial Distribution

  • 00607567211490 ()
709000415

  • Cardiopulmonary bypass system blood tubing set

Rotaflow Pack CD Bioline - 00607567211483

Softshell Venous Reser. 1900ml w. connector 700000292, BEQ-RF32 RotaFlow,Gas Filter
DATASCOPE CORP.
BEQ-T 39705
In Commercial Distribution

  • 00607567211483 ()
709000414

  • Cardiopulmonary bypass system blood tubing set

System 9 CD NXT - 07613327592856

Handpiece
STRYKER CORPORATION
4607000000
In Commercial Distribution

  • 07613327592856 ()
4607-000-000

  • Bone/joint surgical power tool motor, electric

ProNS0 1 CD, 1L - 00840075402152

No Description
Lonza Walkersville, Inc.
BP12-773Q
In Commercial Distribution

  • 00840075402152 ()
BP12-773Q

  • Ex vivo cell culture medium

V-STATS™ Installation CD - 07640121880773

PC based software required a) to configure special (safety-relevant) settings of the SenTec Digital Monitor (SDM), b) to manage ‘SDM Parameters Settings’ and c) to download trend data from the internal memory of the SDM to a PC. It includes features to analyze and view the downloaded trend data. The V-STATS™ software includes the V-CareNeT™ Package, which enables remote monitoring and alarm surveillance for multiple SDMs being connected to the same network as the PC with V-STATS™.
SenTec AG
V-STATS_CD
In Commercial Distribution

  • 07640121880773 ()


  • Transcutaneous blood gas monitoring system
  • Transcutaneous blood gas monitor sensor
  • Pulse Co-oximeter probe, reusable
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