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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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PCRopsis™ BCS Nano (10 mL) is intended for selective precipitation of red blood cells from whole blood at room temperature.
ENTOPSIS, LLC
BCS Nano
Not in Commercial Distribution

  • B55022760100 ()
2276010

  • Red blood cell separation reagent
PCRopsis™ Activator helps mediate room temperature Next Gen Direct PCR™
ENTOPSIS, LLC
Activator
Not in Commercial Distribution

  • B5502280010 ()
228001

  • Nucleic acid extraction/isolation kit IVD
PCRopsis™ BCS Nano (1000 mL) is intended for selective precipitation of red blood cells from whole blood at room temperature.
ENTOPSIS, LLC
BCS Nano
Not in Commercial Distribution

  • B550227610000 ()
22761000

  • Red blood cell separation reagent
Probe, Palm, Lenke, Lumbar, Curved
Wishbone Medical, Inc.
62-2672-31
Not in Commercial Distribution

  • B562772046NS0 ()
62-2672-31

  • Manual orthopaedic bender, reusable
Probe, Palm, Lenke, Lumbar, Straight
Wishbone Medical, Inc.
62-2672-21
Not in Commercial Distribution

  • B562772045NS0 ()
62-2672-21

  • Manual orthopaedic bender, reusable
Zepto Fluid Isolator
MYNOSYS CELLULAR DEVICES, INC.
E1000
In Commercial Distribution

  • B560E10001 ()
  • B560E10000 ()
E1000

  • Electrosurgical handpiece, single-use
Zepto Fluid Isolator with Roller Dispenser
MYNOSYS CELLULAR DEVICES, INC.
12686
Not in Commercial Distribution

  • B560126860 ()
  • B560126861 ()
12686

  • Electrosurgical handpiece, single-use
Zepto Handpiece
MYNOSYS CELLULAR DEVICES, INC.
12430
Not in Commercial Distribution

  • B560124300 ()
  • B560124301 ()
12430

  • Electrosurgical handpiece, single-use
Zepto Handpiece
MYNOSYS CELLULAR DEVICES, INC.
Z1000
In Commercial Distribution

  • B560Z10000 ()
  • B560Z10001 ()
Z1000

  • Electrosurgical handpiece, single-use
Probe, Palm, Duckbill, Lumbar, Straight
Wishbone Medical, Inc.
62-2672-20
Not in Commercial Distribution

  • B562090729NS0 ()
62-2672-20

  • Manual orthopaedic bender, reusable
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