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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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PR System One Style Ultrafine Filters
SUNSET HEALTHCARE SOLUTIONS, INC.
CF1009NTPLC
In Commercial Distribution

  • 00848530089085 ()


  • CPAP/BPAP unit ambient air filter, single-use
ION ONE TOUCH ES DX INST
LIFE TECHNOLOGIES HOLDINGS PTE. LTD.
ONE TOUCH ES DX
In Commercial Distribution

  • 10190302000864 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
White, LWS, with one storage cabinet
SAKURA FINETEK U.S.A., INC.
4171-02
In Commercial Distribution

  • 00615233078186 ()
4171-02

  • Microscope slide cabinet
  • Histology tissue cassette IVD, laboratory processing, single-use
Exchange Select One Step Ovulation Predictor
SPD SWISS PRECISION DIAGNOSTICS GMBH
One Step Ovulation Predictor
Not in Commercial Distribution

  • 00614299396432 ()
  • 00633472000140 ()
  • 10614299396439 ()


  • Natural conception assistance kit
Trephine Burs Surgical Kit One Piece
ACE SURGICAL SUPPLY CO., INC.
0494512
In Commercial Distribution

  • 00614950028368 ()
0494512

  • General surgical procedure kit, non-medicated, reusable
Separating strips, coated on one side
DENTAURUM GmbH & Co.KG
018-002-00
Not in Commercial Distribution

  • J011018002000 ()
  • J011018002001 ()


  • Dental abrasive strip, single-use
PR System One Style Foam Filter
SUNSET HEALTHCARE SOLUTIONS, INC.
BAY0151009F-1
In Commercial Distribution

  • 00848530092375 ()


  • CPAP/BPAP unit ambient air filter, single-use
PR System One Style Ultrafine Filters
SUNSET HEALTHCARE SOLUTIONS, INC.
ABUC001CF1009-2
In Commercial Distribution

  • 00848530092016 ()


  • CPAP/BPAP unit ambient air filter, single-use
PR System One Style Ultrafine Filters
SUNSET HEALTHCARE SOLUTIONS, INC.
ACPA041CF1009NTPLC
In Commercial Distribution

  • 00848530091767 ()


  • CPAP/BPAP unit ambient air filter, single-use
PR System One Style Ultrafine Filters
SUNSET HEALTHCARE SOLUTIONS, INC.
ACPA050CF1009NTPLC
In Commercial Distribution

  • 00848530091750 ()


  • CPAP/BPAP unit ambient air filter, single-use
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