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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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High Power Single-Use Laser Fiber
BOSTON SCIENTIFIC CORPORATION
M006R8403930
Not in Commercial Distribution

  • 08714729963806 ()
  • 08714729963790 ()

  • 550 um Diameter


  • General/multiple surgical laser system beam guide, single-use
High Power Single-Use Laser Fiber
BOSTON SCIENTIFIC CORPORATION
M006R8403920
Not in Commercial Distribution

  • 08714729963783 ()
  • 08714729963776 ()

  • 365 um Diameter


  • General/multiple surgical laser system beam guide, single-use
High Power Single-Use Laser Fiber
BOSTON SCIENTIFIC CORPORATION
M006R8403910
Not in Commercial Distribution

  • 08714729963769 ()
  • 08714729963752 ()

  • 242 um Diameter


  • General/multiple surgical laser system beam guide, single-use
Declassified as non-medical device. "EZ-ID Tape System Vibrant, System comes with eight 3 ft. rolls of tape and a rack that holds them organized and accessible for use 1x3ft rolls of Neon Blue 1x3ft rolls of Neon Yellow 1x3ft roll of Neon Green 1x3ft roll of Neon Orange 2x3ft roll of Neon Purple 2x3ft roll of Neon Pink"
ZIRC DENTAL PRODUCTS, INC.
70Z310
Not in Commercial Distribution

  • 00840161305671 ()

  • Length: 91.4 Centimeter


  • Surgical instrument track identification tape
Declassified as non-medical device. E-Z ID Tape Roll Neon Pink-10ft
ZIRC DENTAL PRODUCTS, INC.
70Z300S
Not in Commercial Distribution

  • 00840161305657 ()

  • Length: 305 Centimeter


  • Surgical instrument track identification tape
Declassified as non-medical device. E-Z ID Tape Roll Neon Purple-10ft
ZIRC DENTAL PRODUCTS, INC.
70Z300R
Not in Commercial Distribution

  • 00840161305640 ()

  • Length: 305 Centimeter


  • Surgical instrument track identification tape
Declassified as non-medical device. E-Z ID Tape Roll Neon Orange-10ft
ZIRC DENTAL PRODUCTS, INC.
70Z300Q
Not in Commercial Distribution

  • 00840161305633 ()

  • Length: 305 Centimeter


  • Surgical instrument track identification tape
Declassified as non-medical device. E-Z ID Tape Roll Neon Yellow-10ft
ZIRC DENTAL PRODUCTS, INC.
70Z300O
Not in Commercial Distribution

  • 00840161305619 ()

  • Length: 305 Centimeter


  • Surgical instrument track identification tape
Declassified as non-medical device. E-Z ID Tape Roll Copper-10ft
ZIRC DENTAL PRODUCTS, INC.
70Z300U
Not in Commercial Distribution

  • 00840161305596 ()

  • Length: 305 Centimeter


  • Surgical instrument track identification tape
The ID CORE CONTROL kit consists of 2 sets of recombinant synthetic DNA plasmids to be used as positive controls to evaluate the performance of the ID CORE XT test(Kit Product Number: 1021720000). The ID CORE CONTROL kit contains two separate vials: ID CORE CONTROL 1 and ID CORE CONTROL 2, both composed of synthetic plasmid pools to be used as assayed positive controls for alternate alleles (alleles 1 and 2, respectively) of the 29 polymorphisms assayed by ID CORE XT. Both control vials must be used in every run of the ID CORE XT test as positive controls for the correct detection of the polymorphism genotypes interrogated by the test. Each control has expected polymorphism genotypes results in the ID CORE XT test when analyzed by the ID CORE XT ANALYSIS SOFTWARE and will produce a valid or invalid run result. ID CORE XT is a qualitative, polymerase chain reaction (PCR) and hybridization-based genotyping test for the simultaneous identification of multiple alleles encoding human erythrocyte antigens (HEAs) in human genomic DNA. ID CORE XT interrogates 29 polymorphisms to predict 53 HEA allele genotypes and 37 antigen phenotypes of the following blood group systems: Rh, Kell, Kidd, Duffy, MNS, Diego, Dombrock, Colton, Cartwright and Lutheran, as an alternative to serology.
PROGENIKA BIOPHARMA, SA
v1
In Commercial Distribution

  • 08437013457040 ()
1301790000

  • Multiple blood group genotyping IVD, control
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