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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® Spinal System - 00721902575242

SCREW 8655535 CDH 5.5 TULIP 5MMX35MM ASY
MEDTRONIC SOFAMOR DANEK, INC.
8655535
In Commercial Distribution

  • 00721902575242 ()

  • Outer Diameter: 5.0 Millimeter
  • Length: 35.0 Millimeter


  • Spinal bone screw, non-bioabsorbable

ProNS0 1 CD, 1L - 00840075402152

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

  • 00840075402152 ()
BP12-773Q

  • Ex vivo cell culture medium

CD 103 / ITGAE RMab - B502BSB28640

CD103 is a rabbit monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Concentrate, 1 ml
In Commercial Distribution

  • B502BSB28640 ()
BSB 2864

  • CD103 cell marker IVD, antibody

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

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

CMSViewer CD(review FDA) - 06944904086439

No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
115-034055-00
In Commercial Distribution

  • 06944904086439 ()


  • Noninvasive device battery charger

CD Horizon Spinal System - 00885074442082

LEGACY ILIAC, TI, CMAS IMP TRY
MEDTRONIC SOFAMOR DANEK, INC.
7043120
In Commercial Distribution

  • 00885074442082 ()


  • Instrument tray, reusable

CD HORIZON Spinal System - 00643169623682

ROTATION ROD 653101500 500X5.5MM TI AL S
MEDTRONIC SOFAMOR DANEK, INC.
653101500
Not in Commercial Distribution

  • 00643169623682 ()

  • Length: 500.0 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system, sterile
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