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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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CUTFIX - 04038653865086

CUTFIX Disposable Scalpel, polymer handle, Fig. 24, stainless steel, sterile, disposable, package of 10 pieces
Aesculap AG
5518091
In Commercial Distribution

  • 04038653472734 ()
  • 04038653865086 ()
  • 04045439038633 ()
5518091

  • Scalpel, single-use

INCORPORATE - 00840916125929

InCORPorate VBR Implant 40 W x 30 L x 24 H mm 10 degree Lordotic
SPINAL ELEMENTS
104-1-40302410
In Commercial Distribution

  • 00840916125929 ()


  • Polymeric spinal interbody fusion cage

INCORPORATE - 00840916125547

InCORPorate VBR Implant 33 W x 28 L x 24 H mm 10 degree Lordotic
SPINAL ELEMENTS
104-1-33282410
In Commercial Distribution

  • 00840916125547 ()


  • Polymeric spinal interbody fusion cage

TIDIShield - 01618125152420

TIDIShield Slush/Warming Machine Covers Polyurethane Sterile 44in x 44in x 1in 24 per Case
TIDI PRODUCTS, LLC
531903
Not in Commercial Distribution

  • 01618125152420 ()


  • Urological fluid funnel, sterile

TandemLife LifeSPARC - 00814112020708

LifeSPARC Blood Pump, TandemLung Oxygenator, 15 Fr Arterial Cannula, 24 Fr Venous Cannnula and accessories
CARDIACASSIST, INC.
5840-2415
Not in Commercial Distribution

  • 00814112020708 ()


  • Cardiopulmonary bypass system centrifugal pump
  • Extracorporeal membrane oxygenator
  • Cardiopulmonary bypass system mounting unit
  • Vascular dilator, single-use
  • Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage
  • Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, return

TandemLife LifeSPARC - 00814112020692

LifeSPARC Blood Pump, TandemLung Oxygenator, 17 Fr Arterial Cannula, 24 Fr Venous Cannula, and accessories
CARDIACASSIST, INC.
5840-2417
Not in Commercial Distribution

  • 00814112020692 ()


  • Cardiopulmonary bypass system centrifugal pump
  • Extracorporeal membrane oxygenator
  • Cardiopulmonary bypass system mounting unit
  • Vascular dilator, single-use
  • Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage
  • Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, return

ICU Medical - 00887709075320

82" Trifuse 15 Drop 24 Hour Admin Set w/Inj Site, Bravo24®, Rotating Luer
ICU MEDICAL, INC.
B99322
In Commercial Distribution

  • 10887709075327 ()
  • 00887709075320 ()


  • Basic intravenous administration set, noninvasive

ICU Medical - 00887709056824

139" 15 Drop 24 Hour Primary Set w/4 Bravo24®, 3-Way Stopcock, Rotating Luer
ICU MEDICAL, INC.
B99256
In Commercial Distribution

  • 10887709056821 ()
  • 00887709056824 ()


  • Basic intravenous administration set, noninvasive

ICU Medical - 00887709123311

Transpac™ IT MONITORING KIT NEONATAL, 24", DISPOSABLE TRANSDUCER, 30 ML SQUEEZE FLUSH (INFUSION PUMP)
ICU MEDICAL, INC.
42800-24
In Commercial Distribution

  • 10887709123318 ()
  • 00887709123311 ()
42800-24

  • Invasive blood pressure transducer set

ICU Medical - 00887709120785

Transpac IT Monitoring Kit, 24" Safeset Reservoir, Blood Sampling Port, 3ml Flush Device, Un-Bonded Macrodrip
ICU MEDICAL, INC.
42801-29
In Commercial Distribution

  • 10887709120782 ()
  • 00887709120785 ()
42801-29

  • Invasive blood pressure transducer set
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