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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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ColpoWave Balloon blister pack containing one sterile unit
SURGITOOLS PTY. LTD.
CBD
In Commercial Distribution

  • 09351599000119 ()


  • Colpotomy tube
WRAP,CSR,GEMINI,24X24,ONE PLY,REG WGT
MEDLINE INDUSTRIES, INC.
GEM2124
In Commercial Distribution

  • 10080196921249 ()
GEM2124

  • Sterilization packaging, single-use
iNAP One sleep therapy system whole set package
SOMNICS, INC.
91000-07
In Commercial Distribution

  • 04719878320009 ()
91000-07

  • Intraoral negative-pressure sleep apnoea unit
Three In One Respiratory Care System- Inspiratory Filter
FISHER & PAYKEL HEALTHCARE LIMITED
RT016
In Commercial Distribution

  • 09420012429377 ()
  • 09420012432339 ()
RT016

  • Microbial medical gas filter, single-use
PR System One Style Ultrafine Filter - No Tab
SUNSET HEALTHCARE SOLUTIONS, INC.
BAY0151009NT1
In Commercial Distribution

  • 00848530092399 ()


  • CPAP/BPAP unit ambient air filter, single-use
PR System One Style Ultrafine Filters - No Tab
SUNSET HEALTHCARE SOLUTIONS, INC.
BAY0151009NT
In Commercial Distribution

  • 00848530092382 ()


  • CPAP/BPAP unit ambient air filter, single-use
PR System One Style Ultrafine Filters - No Tab
SUNSET HEALTHCARE SOLUTIONS, INC.
BAY0151009NT2
In Commercial Distribution

  • 00848530092320 ()


  • CPAP/BPAP unit ambient air filter, single-use
Unisoft ONE Single Patient Use Alternating Pressure Mattress
Unisoft Medical Corporation
UO-SPUM-800
In Commercial Distribution

  • 00863220000416 ()
UO-SPUM-800

  • Alternating-pressure bed mattress
Unisoft ONE Single Patient Use Therapeutic Support System
Unisoft Medical Corporation
UO-SPUS-800
In Commercial Distribution

  • 00863220000409 ()
UO-SPUS-800

  • Alternating-pressure bed mattress system
PROC Venus Bulk Flow ONE Kit 1x2G SYR
Kulzer GmbH
66098279
In Commercial Distribution

  • J014660982790 ()
66098279

  • Dental composite resin
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