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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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USED LP1000 CONFIG UNIT1000AAAABAAACBBAAAAAAAAA
PHYSIO-CONTROL, INC.
99425
In Commercial Distribution

  • 00883873778876 ()
99425-000025U

  • Non-rechargeable professional semi-automated external defibrillator
The Access AFP assay is a paramagnetic particle, chemiluminescent immunoassay for use with the Access Immunoassay Systems for the quantitative determination of alpha-fetoprotein (AFP) in: 1. Human serum, as an aid in the management of patients with non-seminomatous testicular cancer. 2. Maternal serum and amniotic fluid at 15 to 20 weeks gestation, to aid in the detection of fetal open neural tube defects (ONTD). Test results, when used in conjunction with ultrasonography, are safe and effective aids in the detection of fetal ONTD. The assay is intended for use in conjunction with other diagnostic tools such as ultrasound and amniography.
Beckman Coulter, Inc.
33211
In Commercial Distribution

  • H628332111 ()
33211

  • Trisomy 21-risk hormone IVD, kit, chemiluminescent immunoassay
External Pulse Generator, 2 Port Header
ADVANCED NEUROMODULATION SYSTEMS, INC.
3042
In Commercial Distribution

  • 05415067051882 ()
3042

  • Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator
No Description
MEDINOL LTD.
LUN275R38US
Not in Commercial Distribution

  • 07290107014564 ()

  • Length: 38 Millimeter
  • Lumen/Inner Diameter: 2.75 Millimeter


  • Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated
CONFIG LP20E CMM,ENG
PHYSIO-CONTROL, INC.
99507
In Commercial Distribution

  • 00883873853962 ()
99507-000112

  • Physiologic-monitoring defibrillation system
CONFIG LP20E CMM,PCNG,ENG
PHYSIO-CONTROL, INC.
99507
In Commercial Distribution

  • 00883873853863 ()
99507-000122

  • Physiologic-monitoring defibrillation system
CONFIG LP20E CMM,PCNG,SPO2,ENG
PHYSIO-CONTROL, INC.
99507
In Commercial Distribution

  • 00883873852804 ()
99507-000132

  • Physiologic-monitoring defibrillation system
CONFIG LP20E CMM,PCNG,MNC,SPO2,ENG
PHYSIO-CONTROL, INC.
99507
In Commercial Distribution

  • 00883873852798 ()
99507-000133

  • Physiologic-monitoring defibrillation system
LP20 - CONFIGD,AHA 2005,PACING,SPO2,ENG
PHYSIO-CONTROL, INC.
97402
In Commercial Distribution

97402-000007

  • Physiologic-monitoring defibrillation system
LP20-CONFIGURED,W/PACING,SPO2,ENGLISH
PHYSIO-CONTROL, INC.
97402
In Commercial Distribution

97402-000003

  • Physiologic-monitoring defibrillation system
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