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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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IsoLED II LED HL - 00816835023998

IsoLED II LED HL, w/ AC Power Pack
Medical Illumination International Inc.
IL-2317-02
In Commercial Distribution

  • 01816835023997 ()
  • 00816835023998 ()


  • Head-worn lamp

ESI - B3964501000

SNARE CORD TO FIT CUSTOMER SPECIFIED POWER UNIT.
FTT MEDICAL, INC.
45-0100
In Commercial Distribution

  • B3964501000 ()


  • Rigid polypectomy snare, single-use

LifeSPARC - 00814112020647

Power cord for blood pump controller charging station
CARDIACASSIST, INC.
5900-0010
Not in Commercial Distribution

  • 00814112020647 ()


  • Cardiopulmonary bypass system centrifugal pump drive unit

Integra® - 10381780168768

Integra® AC/DC Direct-Link Power Kit - US
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
90550US
In Commercial Distribution

  • M43390550US1 ()
  • 10381780168768 ()


  • General-purpose light source

Integra® - 10381780168331

Integra® Power Supply, 300W Xenon 100-240 vac
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
600972
Not in Commercial Distribution

  • H8346009721 ()
  • 10381780168331 ()
600972

  • General-purpose light source

Megadyne - 10614559103074

Front Panel With PCB, For Mega Power Generator
MEGADYNE MEDICAL PRODUCTS, INC.
6020094-01
Not in Commercial Distribution

  • 10614559103074 ()


  • Electrosurgical system generator

Megadyne - 10614559103067

Front Panel Without PCB, For Mega Power Generator
MEGADYNE MEDICAL PRODUCTS, INC.
6020093-01
Not in Commercial Distribution

  • 10614559103067 ()


  • Electrosurgical system generator

ORIGINS - 00816995026495

BASKET, BULLET TIP, 5.0MM X 35CM, POWER, NR
SOLTA MEDICAL
810BKBU5035PXNR
In Commercial Distribution

  • 00816995026495 ()
810BKBU5035PXNR

  • Liposuction system cannula, reusable

NormaTec MVP Lower Body Recovery Package - 00817369021498

NormaTec MVP Recovery Package - Lower Body Power Standard
NORMATEC INDUSTRIES LP
NormaTec MVP Recovery Package - Lower Body Power Standard
In Commercial Distribution

  • 00817369021498 ()
40324

  • Intermittent venous compression system
  • Sequential venous compression system

NormaTec MVP Lower Body Recovery Package - 00817369021481

NormaTec MVP Recovery Package - Lower Body Power Short
NORMATEC INDUSTRIES LP
NormaTec MVP Recovery Package - Lower Body Power Short
In Commercial Distribution

  • 00817369021481 ()
40323

  • Sequential venous compression system
  • Intermittent venous compression system
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