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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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MERIFLUOR Cryptosporidium/Giardia (MERIFLUOR C/G) is an in vitro direct immunofluorescent detection procedure for the simultaneous detection of Cryptosporidium oocysts and Giardia cysts in fecal material.
MERIDIAN BIOSCIENCE, INC.
250050
In Commercial Distribution

  • 00840733101113 ()
250050

  • Multiple faecal parasite antigen IVD, kit, direct fluorescent test (DFT)
The Sensifirm device is intended for the treatment of the following medical conditions using non thermal RF combined with massage - Temporary reduction in the appearance of cellulite
EL GLOBAL TRADE LTD
CEL100US04SNS
In Commercial Distribution

  • 05060445341309 ()


  • Radio-frequency skin surface treatment system
The sensiFirm device is intended for the treatment of the following medical conditions using non thermal RF combined with massage - Temporary reduction in the appearance of cellulite
EL GLOBAL TRADE LTD
CEL100US01SNS
In Commercial Distribution

  • 05060445341118 ()


  • Radio-frequency skin surface treatment system
The Trabectome I/A Console (110V) is an aspiration pump intended for use in general surgery applications where aspiration of irrigation waste and waste fluid is desired.
NEOMEDIX CORPORATION
550014
In Commercial Distribution

  • 00854028002023 ()
550014-01

  • Ophthalmic irrigation/aspiration pump
Batlle ICL manipulator, 4 3/4'', vaulted shaft, 12.0mm from bend to tip, round roughened spatula tip, for easy placement of lens under the iris, round handle
AMBLER SURGICAL CORP.
Batlle ICL manipulator
In Commercial Distribution

  • 00190660101169 ()
9421E

  • Ocular hook/spatula/manipulator, reusable
Disposable Medical Face Masks Sanitary Dental Surgical Hypoallergenic with Elastic Ear Loops 3-Ply Thick Resistance to Fluid & Blood Cotton Filter for Pollen Allergies & Dust Box of 50
P&P Medical Surgical LLC
01000
In Commercial Distribution

  • G026010001 ()


  • Surgical/medical face mask, single-use
AMSure® Enteral Administration Kit FOR USE WITH THE SENTINEL® ENTERAL FEEDING PUMP CONTENTS: Enteral Feeding 1200mL Bag Pump Set with ENFit Connector, ENFit Transition Connector
AMSINO INTERNATIONAL, INC.
2
In Commercial Distribution

  • 40704411006559 ()
  • 10704411006558 ()
ENF1200K

  • Enteral feeding kit, adult/paediatric, non-sterile
AMSure® Enteral Administration Kit FOR USE WITH THE SENTINEL® ENTERAL FEEDING PUMP CONTENTS: Enteral Feeding 500mL Bag Pump Set with ENFit Connector, ENFit Transition Connector
AMSINO INTERNATIONAL, INC.
2
In Commercial Distribution

  • 40704411006535 ()
  • 10704411006534 ()
ENF500K

  • Enteral feeding kit, adult/paediatric, non-sterile
Tethys H10 is intended only for the washing and/or thermal disinfection of re-usable surgical instruments able to resist to a temperature of at least 80°C.
CEFLA SOCIETA' COOPERATIVA
Tethys H10
In Commercial Distribution

  • 08033837931331 ()
M7E200310

  • Ultrasonic-cleaning water bath
  • Surgical utensil washer/disinfector
SUTURE 3-0, PGA-PCL, Undyed Monofilament, U.S.P. except for diameter 3-0 (2.0 Metric) 18"/46cm Synthetic Absorbable Surgical Suture, DSM19 Precision Reverse Cutting 3/8 Circle 19 mm
MCKESSON MEDICAL-SURGICAL INC.
SY497G
In Commercial Distribution

  • 10612479189925 ()
  • 20612479189939 ()


  • Poliglecaprone suture
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