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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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VL - 04035479145293

No Description
BIOTRONIK SE & Co. KG
106157
In Commercial Distribution

  • 04035479000462 ()
  • 04035479145293 ()
106157

  • Vein pick

OBALON® Inflation Can - 00859810006210

OBALON® Inflation Can - component to inflate the OBALON® Balloon System
Reshape Lifesciences Inc.
8200-0001
Not in Commercial Distribution

  • 10859810006217 ()
  • 00859810006210 ()


  • Appetite-suppression gastric balloon inflation gas cartridge

LeukoStrat - 00850052003739

The LeukoStrat CDx FLT3 Mutation Assay is a PCR-based in vitro diagnostic test designed to detect internal tandem duplication (ITD) and tyrosine kinase domain (TKD) mutations D835 and I836 in the FLT3 gene in genomic DNA extracted from mononuclear cells obtained from peripheral blood or bone marrow aspirates of patients diagnosed with acute myelogenous leukemia (AML).
INVIVOSCRIBE, INC.
850052003739
Not in Commercial Distribution

  • 00850052003739 ()
K4120361

  • Acute myeloid leukaemia (AML) genetic mutation IVD, kit, nucleic acid technique (NAT)

LeukoStrat - 00850052003685

The LeukoStrat CDx FLT3 Mutation Assay targets regions of the FLT3 gene to identify internal tandem duplication (ITD) mutations and tyrosine kinase domain (TKD) mutations, such as the D835 and I836 mutations. The LeukoStrat CDx FLT3 Mutation Assay includes reagents, equipment, software and procedures for isolating mononuclear cells and extracting DNA from patient specimens to determine if FLT3 mutations are present. DNA is amplified via PCR, TKD amplicon is enzymatically digested, and the amplicons are detected via capillary electrophoresis.
INVIVOSCRIBE, INC.
850052003685
Not in Commercial Distribution

  • 00850052003685 ()
K4120221

  • Acute myeloid leukaemia (AML) genetic mutation IVD, kit, nucleic acid technique (NAT)

NA - 00802526585821

Power Adapter
BOSTON SCIENTIFIC CORPORATION
6689
In Commercial Distribution

  • 00802526585821 ()


  • Electrical mains power cable

NA - 00802526585807

Power Cord
BOSTON SCIENTIFIC CORPORATION
6175
In Commercial Distribution

  • 00802526585807 ()


  • Electrical mains power cable

NA - 05414734402569

AC Line Cord
ST. JUDE MEDICAL, INC.
3714
In Commercial Distribution

  • 05414734402569 ()
3714

  • Electrical mains power cable

LC PowerCel™ Adapter - 00840094448957

No Description
Advanced Bionics, LLC
CI-2000
In Commercial Distribution



  • Electrical mains power cable

PowerCel™ Adapter - 00840094448926

No Description
Advanced Bionics, LLC
CI-7402
In Commercial Distribution



  • Electrical mains power cable

Naida CI Power Adapter - 00840094452732

No Description
Advanced Bionics, LLC
CI-7455-100
In Commercial Distribution



  • Electrical mains power cable
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