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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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Medicore Co., Ltd.
SA-3000P
In Commercial Distribution

  • 10191237000011 ()
  • 00191237000014 ()
SA-3000P

  • Sphygmograph
Airlife™ Isothermal™ Breathing Circuit Pediatric Respiratory Circuit Heated
Carefusion Corporation
10195-HS3
Not in Commercial Distribution

  • 50885403026575 ()
  • 10885403026577 ()
10195-HS3

  • Airway pressure monitor, non-powered
  • Ventilator breathing circuit, single-use
Single Strand Pre-Sutured Tendon
Rti Surgical, Inc.
4561SC
In Commercial Distribution

  • 00191083047683 ()

  • Folded Diameter: 8.5-12mm Length: 180-220mm
4561SC

  • Tendon graft
Airlife™ Isothermal™ Breathing Circuit Pediatric Respiratory Circuit Heated
Carefusion Corporation
10192-HS3
Not in Commercial Distribution

  • 50885403026551 ()
  • 10885403026553 ()
10192-HS3

  • Breathing circuit condensate trap, reusable
  • Ventilator breathing circuit, single-use
  • Airway pressure monitor, non-powered
Sterilization Case
Rti Surgical, Inc.
55-CASE
In Commercial Distribution

  • 00191083047416 ()
55-CASE

  • Device sterilization/disinfection container, reusable
Airlife™ Isothermal™ Breathing Circuit Adult Inspiratory Line Heated
Carefusion Corporation
1005-H05
Not in Commercial Distribution

  • 50885403026513 ()
  • 10885403026515 ()
1005-H05

  • Ventilator breathing circuit, single-use
Distractor, Foot and Ankle Wedge
Rti Surgical, Inc.
55-DISTRACTOR
In Commercial Distribution

  • 00191083047393 ()
55-DISTRACTOR

  • Orthopaedic surgical distractor, external
PATTERSON TROCAR MED SHEATH 8.4MM 7-1/2
STERIS CORPORATION
CH2804
In Commercial Distribution

  • 10885403026478 ()
CH2804

  • ENT trocar blade
EVANS TRIAL ASSEMBLY, 12mm
Rti Surgical, Inc.
55-E-22-22-12
In Commercial Distribution

  • 00191083047379 ()
55-E-22-22-12

  • Surgical implant/trial-implant/sizer holder, reusable
PATTERSON TROCAR LARGE SHEATH 11.4MM 8IN
STERIS CORPORATION
CH2800
In Commercial Distribution

  • 10885403026454 ()
CH2800

  • ENT trocar blade
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