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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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Angel Whole Blood Processing System - 00852714003071

Angel Whole Blood Processing System Machine (EU) New with 966003051 EU Case Label for New EU Machines
NUO THERAPEUTICS INC
976000101
In Commercial Distribution

  • 00852714003071 ()


  • Apheresis system

Sensimatic® - 00810000520046

New Indifferent Plate & Red Cable for Sensimatic® 600SE (Complies with New FDA Lead Wire Regulations)(Korea)
PARKELL, INC.
D601-K
Not in Commercial Distribution

  • 00810000520046 ()
D601-K

  • Electrosurgical return electrode, reusable

NEW CHOICE PLUS - 00677421001116

New Choice Plus One Step Pregnancy Test
SCI Medic, Inc.
00111
In Commercial Distribution

  • 00677421001116 ()


  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical

Unimed - 06936735493715

ECG Monitor Trunk Cable Philips NEW Style
Unimed Medical Supplies, Inc.
NEPH2031-UE
In Commercial Distribution

  • 06936735493715 ()


  • Electrocardiographic lead set, reusable

Medline Industries, Inc. - 10195327598860

RHK, US, NEW MTO RIGHT HEART K
MEDLINE INDUSTRIES, INC.
VASC1490
In Commercial Distribution

  • 40195327598861 ()
  • 10195327598860 ()
VASC1490

  • General surgical procedure kit, non-medicated, single-use

Honan Intraocular Pressure Reducer - 00851607007196

BLACK BULB W/ FILTER & RING (NEW STYLE)
LEBANON CORP, THE
560
In Commercial Distribution

  • 00851607007196 ()


  • Intraocular pressure-reducing compression system

Medline Industries, Inc. - 10889942379477

LEE PICC KIT W/ NEW GW & PREV
MEDLINE INDUSTRIES, INC.
PICCLEE41-01A
In Commercial Distribution

  • 10889942379477 ()
PICCLEE41-01A

  • General surgical procedure kit, medicated

CARDINAL HEALTH - 10887488616865

KIT,G 3 VALVE,NEW YORK HOSPIT
Cardinal Health 200, LLC
PCV2VR942
In Commercial Distribution

  • 50887488616863 ()
  • 10887488616865 ()
PCV2VR942

  • Cardiothoracic surgical procedure kit, medicated, single-use

CARDINAL HEALTH - 10887488615455

KIT,G 3 CABG,NEW YORK HOSPITAL
Cardinal Health 200, LLC
PCV2CG922
In Commercial Distribution

  • 50887488615453 ()
  • 10887488615455 ()
PCV2CG922

  • Cardiothoracic surgical procedure kit, medicated, single-use

CARDINAL HEALTH - 10887488610702

KIT,G3 CABG,NEW YORK HOSPITA P
Cardinal Health 200, LLC
PCV2CG93W
In Commercial Distribution

  • 50887488610700 ()
  • 10887488610702 ()
PCV2CG93W

  • Cardiothoracic surgical procedure kit, medicated, single-use
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