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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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IPS e.max Ceram - DIVO6813291

IPS e.max Ceram Power Dentin 20 g A2
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
681329
In Commercial Distribution

  • DIVO6813291 ()
681329

  • Dental appliance fabrication material, ceramic

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

Med4 Elite - 00812120002570

Power Cord, Med4 Elite, AS/NZS 4417 15A
Avanos Medical, Inc.
303843
In Commercial Distribution

  • 00812120002570 ()


  • Circulating-fluid localized thermal/compression therapy system control unit

Med4 Elite - 00812120002563

Power Cord, Med4 Elite, IRAM 2073:2009 Argentina
Avanos Medical, Inc.
303842
In Commercial Distribution

  • 00812120002563 ()


  • Circulating-fluid localized thermal/compression therapy system control unit

Med4 Elite - 00812120002495

Power Cord, Med4 Elite, NEMA 5-15P, North America
Avanos Medical, Inc.
303835
In Commercial Distribution

  • 00812120002495 ()


  • Circulating-fluid localized thermal/compression therapy system control unit

LinkStation MINI Evaluation Kit - 00816818020549

LinkStation MINI Evaluation Kit with Italy power cord
ORTHOSENSOR INC
LinkStation MINI Evaluation Kit
Not in Commercial Distribution

  • 00816818020549 ()
05000-505

  • Arthroplasty force sensor display unit

ORIGINS - 00816995026495

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

  • 00816995026495 ()
810BKBU5035PXNR

  • Liposuction system cannula, reusable

ORIGINS - 00816995026471

BASKET, BULLET, 4.0MM X 20CM, POWER HUB, NR
SOLTA MEDICAL
810BKBU4020PXNR
In Commercial Distribution

  • 00816995026471 ()
810BKBU4020PXNR

  • Liposuction system cannula, reusable
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