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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 - 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
Style 900 Isolation Gown One Size Children National
PATIENTSTYLE MEDICAL LLC
900 ISO O/S CN
In Commercial Distribution

  • 00850011216392 ()


  • Patient gown, reusable
Trach O-Life Tracheostomy Care Kit, One Tray Compartment
CUTTING EDGE HC BRANDS LLC
RTG-02500
In Commercial Distribution

  • 10850108006445 ()
  • 00850108006448 ()
RTG-02500

  • Tracheostomy care kit, single-use
KWV-LT : KwikVac Liquid Trap / 20pcs in one box
Medisourcenet, Inc
KWV-LT
In Commercial Distribution

  • 00850034735030 ()


  • Surgical plume evacuation system
Splint and Planning Kit, Orthognathic Kit, one Splint
Materialise NV
SD900.009
In Commercial Distribution

  • 05420060350580 ()
SD900.009

  • Removable dental occlusal splint, custom-made
COFIELD2 ONE PIECE HUM TRIAL 8MM X 145MM
Smith & Nephew, Inc.
71249508
Not in Commercial Distribution

  • 03596010472793 ()
71249508

  • Humeral stem prosthesis trial, reusable
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