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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 - 00643169596306

TRAY 1665006 MAST SCR TRAY
MEDTRONIC SOFAMOR DANEK, INC.
1665006
In Commercial Distribution

  • 00643169596306 ()


  • Instrument tray, reusable

CD HORIZON Spinal System - 00643169596290

TRAY 1665005 5.5-6.0 TLIF DISTRACTOR
MEDTRONIC SOFAMOR DANEK, INC.
1665005
In Commercial Distribution

  • 00643169596290 ()


  • Instrument tray, reusable

CD HORIZON Spinal System - 00643169596283

TRAY 1665004 HYBRID IMPLANT TRAY
MEDTRONIC SOFAMOR DANEK, INC.
1665004
Not in Commercial Distribution

  • 00643169596283 ()


  • Instrument tray, reusable

CD HORIZON Spinal System - 00643169596276

TRAY 1665003 4.75 HYBRID CONFIG LOWER
MEDTRONIC SOFAMOR DANEK, INC.
1665003
Not in Commercial Distribution

  • 00643169596276 ()


  • Instrument tray, reusable

CD HORIZON Spinal System - 00643169596269

TRAY 1665002 4.75 HYBRID CONFIG UPPER
MEDTRONIC SOFAMOR DANEK, INC.
1665002
Not in Commercial Distribution

  • 00643169596269 ()


  • Instrument tray, reusable

CD HORIZON Spinal System - 00643169596252

TRAY 1665001 UNIVERSAL INSTRUMENT LOWER
MEDTRONIC SOFAMOR DANEK, INC.
1665001
Not in Commercial Distribution

  • 00643169596252 ()


  • Instrument tray, reusable

CD HORIZON Spinal System - 00643169596245

TRAY 1665000 UNIVERSAL INSTRUMENT UPPER
MEDTRONIC SOFAMOR DANEK, INC.
1665000
Not in Commercial Distribution

  • 00643169596245 ()


  • Instrument tray, reusable

CD HORIZON Spinal System - 00643169596238

LID 1665011 TAB EXTENDER CAP MODULE LID
MEDTRONIC SOFAMOR DANEK, INC.
1665011
Not in Commercial Distribution

  • 00643169596238 ()


  • Instrument tray, reusable

CD HORIZON Spinal System - 00643169596221

LID 1665010 TAB EXTENDER MODULE LID
MEDTRONIC SOFAMOR DANEK, INC.
1665010
Not in Commercial Distribution

  • 00643169596221 ()


  • Instrument tray, 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

PowerCHO-2 CD - 1L bottle - 05407010127614

No Description
Lonza Verviers
BESP1429Q
In Commercial Distribution

  • 05407010127614 ()
BESP1429Q

  • Ex vivo cell culture medium

PowerCHO-2 CD - 50L bag - 05407010127607

No Description
Lonza Verviers
BESP1429P50
In Commercial Distribution

  • 05407010127607 ()
BESP1429P50

  • Ex vivo cell culture medium

PowerCHO-2 CD - 200L bag - 05407010127591

No Description
Lonza Verviers
BESP1429P200
In Commercial Distribution

  • 05407010127591 ()
BESP1429P200

  • Ex vivo cell culture medium

ProNS0 1 CD, 1L - 05407010122886

No Description
Lonza Verviers
BP12-773Q
In Commercial Distribution

  • 05407010122886 ()


  • Cell culture medium IVD

CD® Spinal System - 00721902575327

SCREW 8655640 CDH 5.5 TULIP 6MMX40MM ASY
MEDTRONIC SOFAMOR DANEK, INC.
8655640
In Commercial Distribution

  • 00721902575327 ()

  • Length: 40.0 Millimeter
  • Outer Diameter: 6.0 Millimeter


  • Spinal bone screw, non-bioabsorbable

CD® Spinal System - 00721902575280

SCREW 8655635 CDH 5.5 TULIP 6MMX35MM ASY
MEDTRONIC SOFAMOR DANEK, INC.
8655635
In Commercial Distribution

  • 00721902575280 ()

  • Outer Diameter: 6.0 Millimeter
  • Length: 35.0 Millimeter


  • Spinal bone screw, non-bioabsorbable

CD® Spinal System - 00721902575259

SCREW 8655540 CDH 5.5 TULIP 5MMX40MM ASY
MEDTRONIC SOFAMOR DANEK, INC.
8655540
In Commercial Distribution

  • 00721902575259 ()

  • Outer Diameter: 5.0 Millimeter
  • Length: 40.0 Millimeter


  • Spinal bone screw, non-bioabsorbable

CD® Spinal System - 00721902575372

SCREW 8655750 CDH 5.5 TULIP 7MMX50MM ASY
MEDTRONIC SOFAMOR DANEK, INC.
8655750
In Commercial Distribution

  • 00721902575372 ()

  • Length: 50.0 Millimeter
  • Outer Diameter: 7.0 Millimeter


  • Spinal bone screw, non-bioabsorbable

CD® Spinal System - 00721902575358

SCREW 8655745 CDH 5.5 TULIP 7MMX45MM ASY
MEDTRONIC SOFAMOR DANEK, INC.
8655745
In Commercial Distribution

  • 00721902575358 ()

  • Length: 45.0 Millimeter
  • Outer Diameter: 7.0 Millimeter


  • Spinal bone screw, non-bioabsorbable

CD® Spinal System - 00721902575341

SCREW 8655740 CDH 5.5 TULIP 7MMX40MM ASY
MEDTRONIC SOFAMOR DANEK, INC.
8655740
In Commercial Distribution

  • 00721902575341 ()

  • Length: 40.0 Millimeter
  • Outer Diameter: 7.0 Millimeter


  • Spinal bone screw, non-bioabsorbable

CD® Spinal System - 00721902575334

SCREW 8655645 CDH 5.5 TULIP 6MMX45MM ASY
MEDTRONIC SOFAMOR DANEK, INC.
8655645
In Commercial Distribution

  • 00721902575334 ()

  • Length: 45.0 Millimeter
  • Outer Diameter: 6.0 Millimeter


  • Spinal bone screw, non-bioabsorbable

CD® Spinal System - 00721902575273

SCREW 8655545 CDH 5.5 TULIP 5MMX45MM ASY
MEDTRONIC SOFAMOR DANEK, INC.
8655545
In Commercial Distribution

  • 00721902575273 ()

  • Outer Diameter: 5.0 Millimeter
  • Length: 45.0 Millimeter


  • Spinal bone screw, non-bioabsorbable

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

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

System 9 CD NXT - 07613327592856

Handpiece
STRYKER CORPORATION
4607000000
In Commercial Distribution

  • 07613327592856 ()
4607-000-000

  • Bone/joint surgical power tool motor, electric

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

ProNS0 1 CD, 1L - 00840075402152

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

  • 00840075402152 ()
BP12-773Q

  • Ex vivo cell culture medium

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

CD HORIZON Spinal System - 00643169623675

ROTATION ROD 653101480 480X5.5MM TI AL S
MEDTRONIC SOFAMOR DANEK, INC.
653101480
Not in Commercial Distribution

  • 00643169623675 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 480.0 Millimeter


  • Bone-screw internal spinal fixation system, sterile

CD HORIZON Spinal System - 00643169623668

ROTATION ROD 653101460 460X5.5MM TI AL S
MEDTRONIC SOFAMOR DANEK, INC.
653101460
Not in Commercial Distribution

  • 00643169623668 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 460.0 Millimeter


  • Bone-screw internal spinal fixation system, sterile

CD HORIZON Spinal System - 00643169623651

ROTATION ROD 653101440 440X5.5MM TI AL S
MEDTRONIC SOFAMOR DANEK, INC.
653101440
Not in Commercial Distribution

  • 00643169623651 ()

  • Length: 440.0 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system, sterile

CD HORIZON Spinal System - 00643169623644

ROTATION ROD 653101420 420X5.5MM TI AL S
MEDTRONIC SOFAMOR DANEK, INC.
653101420
Not in Commercial Distribution

  • 00643169623644 ()

  • Length: 420.0 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system, sterile

CD HORIZON Spinal System - 00643169623637

ROTATION ROD 653101400 400X5.5MM TI AL S
MEDTRONIC SOFAMOR DANEK, INC.
653101400
Not in Commercial Distribution

  • 00643169623637 ()

  • Length: 400.0 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system, sterile

CD HORIZON Spinal System - 00643169623620

ROTATION ROD 653101380 380X5.5MM TI AL S
MEDTRONIC SOFAMOR DANEK, INC.
653101380
Not in Commercial Distribution

  • 00643169623620 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 380.0 Millimeter


  • Bone-screw internal spinal fixation system, sterile

CD HORIZON Spinal System - 00643169623613

ROTATION ROD 653101360 360X5.5MM TI AL S
MEDTRONIC SOFAMOR DANEK, INC.
653101360
Not in Commercial Distribution

  • 00643169623613 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 360.0 Millimeter


  • Bone-screw internal spinal fixation system, sterile

CD HORIZON Spinal System - 00643169623606

ROTATION ROD 653101340 340X5.5MM TI AL S
MEDTRONIC SOFAMOR DANEK, INC.
653101340
Not in Commercial Distribution

  • 00643169623606 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 340.0 Millimeter


  • Bone-screw internal spinal fixation system, sterile

CD HORIZON Spinal System - 00643169623590

ROTATION ROD 653101320 320X5.5MM TI AL S
MEDTRONIC SOFAMOR DANEK, INC.
653101320
Not in Commercial Distribution

  • 00643169623590 ()

  • Length: 320.0 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system, sterile

CD HORIZON Spinal System - 00643169623583

ROTATION ROD 653101300 300X5.5MM TI AL S
MEDTRONIC SOFAMOR DANEK, INC.
653101300
Not in Commercial Distribution

  • 00643169623583 ()

  • Length: 300.0 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system, sterile

CD HORIZON Spinal System - 00643169623576

ROTATION ROD 653101290 290X5.5MM TI AL S
MEDTRONIC SOFAMOR DANEK, INC.
653101290
Not in Commercial Distribution

  • 00643169623576 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 290.0 Millimeter


  • Bone-screw internal spinal fixation system, sterile

CD HORIZON Spinal System - 00643169623569

ROTATION ROD 653101280 280X5.5MM TI AL S
MEDTRONIC SOFAMOR DANEK, INC.
653101280
Not in Commercial Distribution

  • 00643169623569 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 280.0 Millimeter


  • Bone-screw internal spinal fixation system, sterile

CD HORIZON Spinal System - 00643169623552

ROTATION ROD 653101270 270X5.5MM TI AL S
MEDTRONIC SOFAMOR DANEK, INC.
653101270
Not in Commercial Distribution

  • 00643169623552 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 270.0 Millimeter


  • Bone-screw internal spinal fixation system, sterile

CD HORIZON Spinal System - 00643169623545

ROTATION ROD 653101260 260X5.5MM TI AL S
MEDTRONIC SOFAMOR DANEK, INC.
653101260
Not in Commercial Distribution

  • 00643169623545 ()

  • Length: 260.0 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system, sterile

CD HORIZON Spinal System - 00643169623538

ROTATION ROD 653101250 250X5.5MM TI AL S
MEDTRONIC SOFAMOR DANEK, INC.
653101250
Not in Commercial Distribution

  • 00643169623538 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 250.0 Millimeter


  • Bone-screw internal spinal fixation system, sterile

CD HORIZON Spinal System - 00643169623521

ROTATION ROD 653101240 240X5.5MM TI AL S
MEDTRONIC SOFAMOR DANEK, INC.
653101240
Not in Commercial Distribution

  • 00643169623521 ()

  • Length: 240.0 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system, sterile

CD HORIZON Spinal System - 00643169623514

ROTATION ROD 653101230 230X5.5MM TI AL S
MEDTRONIC SOFAMOR DANEK, INC.
653101230
Not in Commercial Distribution

  • 00643169623514 ()

  • Length: 230.0 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system, sterile

CD HORIZON Spinal System - 00643169623507

ROTATION ROD 653101220 220X5.5MM TI AL S
MEDTRONIC SOFAMOR DANEK, INC.
653101220
Not in Commercial Distribution

  • 00643169623507 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 220.0 Millimeter


  • Bone-screw internal spinal fixation system, sterile

CD HORIZON Spinal System - 00643169623491

ROTATION ROD 653101210 210X5.5MM TI AL S
MEDTRONIC SOFAMOR DANEK, INC.
653101210
Not in Commercial Distribution

  • 00643169623491 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 210.0 Millimeter


  • Bone-screw internal spinal fixation system, sterile

CD HORIZON Spinal System - 00643169623484

ROTATION ROD 653101200 200X5.5MM TI AL S
MEDTRONIC SOFAMOR DANEK, INC.
653101200
Not in Commercial Distribution

  • 00643169623484 ()

  • Length: 200.0 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system, sterile

CD HORIZON Spinal System - 00643169623477

ROTATION ROD 653101190 190X5.5MM TI AL S
MEDTRONIC SOFAMOR DANEK, INC.
653101190
Not in Commercial Distribution

  • 00643169623477 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 190.0 Millimeter


  • Bone-screw internal spinal fixation system, sterile
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