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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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Manual & CDs, ANA Screen with MDSS IFU, SW4.1_v2
BIO-RAD LABORATORIES, INC.
SW4.1_V2
Not in Commercial Distribution

  • 00847865001342 ()

  • 1 Each
6651160H

  • Multiple antinuclear antibody (ANA) screening IVD, kit, multiplex
INTER-THERM MINI PAEDIATRIC HMEF WITH LUER PORT - STERILE
Intersurgical Incorporated
1331000S
In Commercial Distribution

  • 05030267109470 ()
  • 05030267109463 ()


  • Heat/moisture exchanger/microbial filter, sterile
K-WIRE 1.6MM X 150MM WITH DOUBLE THREADED TIP
ORTHO SOLUTIONS HOLDINGS LIMITED
OS201314
In Commercial Distribution

  • 05055662922950 ()
  • 05055662922967 ()
OS201314

  • Orthopaedic bone wire
K-WIRE 1.5MM X 75MM WITH THREADED TIP 30MM
ORTHO SOLUTIONS HOLDINGS LIMITED
OS201312
In Commercial Distribution

  • 05055662922752 ()
  • 05055662922769 ()
OS201312

  • Orthopaedic bone wire
K-WIRE 2.5MM X 150MM WITH THREADED TIP 15MM
ORTHO SOLUTIONS HOLDINGS LIMITED
OS201319
In Commercial Distribution

  • 05055662920901 ()
  • 05055662920918 ()
OS201319

  • Orthopaedic bone wire
K-WIRE 2.0MM X 150MM WITH THREADED TIP 15MM
ORTHO SOLUTIONS HOLDINGS LIMITED
OS201318
In Commercial Distribution

  • 05055662920888 ()
  • 05055662920895 ()
OS201318

  • Orthopaedic bone wire
K-WIRE 1.6MM X 150MM WITH THREADED TIP 15MM
ORTHO SOLUTIONS HOLDINGS LIMITED
OS201317
In Commercial Distribution

  • 05055662920864 ()
  • 05055662920871 ()
OS201317

  • Orthopaedic bone wire
Repose Sole Protector x 1 with Small Pump
Frontier Therapeutics Inc
6930001
In Commercial Distribution

  • 05056279303279 ()


  • Heel protector
Repose Small Footprotector (Bulk Pack 10) with Pump
Frontier Therapeutics Inc
6520100
In Commercial Distribution

  • 05056279302296 ()


  • Heel protector
EndoFLIP Measurement Catheter for use with EndoFLIP System
CROSPON LIMITED
EF-322
In Commercial Distribution

  • 05391530810029 ()


  • Oesophageal motility analysis system
  • Manometric gastrointestinal motility analysis system
  • Gastrointestinal barostat
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