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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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"CT - EXTRAVASATION DETECTOR SYS,NON CE (60727064)"
BAYER MEDICAL CARE INC.
XDS 700
In Commercial Distribution

  • 00616258008172 ()
XDS 700

  • CT contrast medium injection system, line-powered, mobile
"ASSY,POLE,IV,SINGLE HOOK (84284246)"
BAYER MEDICAL CARE INC.
MRXP IV S
In Commercial Distribution

  • 00616258008158 ()
MRXP IV S

  • MRI contrast medium injection system, line-powered, mobile
"Assy, IV Pole, MRXperion (84290149)"
BAYER MEDICAL CARE INC.
MRXP IV D
In Commercial Distribution

  • 00616258008141 ()
MRXP IV D

  • MRI contrast medium injection system, line-powered, mobile
"SYSTEM,INJECTOR,MRXPERION (84200085)"
BAYER MEDICAL CARE INC.
MRXperion
In Commercial Distribution

  • 00616258008134 ()
MRXP 200

  • MRI contrast medium injection system, line-powered, mobile
A mechanical device without adjustable parts intended to be placed between the teeth of the upper and lower jaws of a patient to maintain an open oral cavity, typically during emergent placement of an artificial airway or for an oral surgical intervention.
ENTER MEDICAL CORPORATION
PN-2002
In Commercial Distribution

  • 04719872108795 ()


  • Mouth gag, non-adjustable
CUSMED CirFIX® Burr Hole Cover, Radiolucent Revisable Type for Shunt & ICP+Screwdriver, PEEK, 14mm/11mm, Sterile
OSSAWARE BIOTECH CO., LTD.
9906.0014.11S
In Commercial Distribution

  • 04717002404335 ()
  • 14717002404332 ()
  • 24717002404339 ()
9906.0014.11S

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
CUSMED CirFIX® Burr Hole Cover, Radiolucent Revisable Type+Screwdriver, PEEK, 14mm/11mm, Sterile
OSSAWARE BIOTECH CO., LTD.
9905.0014.11S
In Commercial Distribution

  • 14717002404325 ()
  • 04717002404328 ()
  • 24717002404322 ()
9905.0014.11S

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
DRVR KIT 9734649 LGY G4 PEEK RDCTN DRVR
MEDTRONIC NAVIGATION, INC.
9734649
In Commercial Distribution

  • 00613994792846 ()


  • Surgical screwdriver, reusable
MAJ-1720 Probe driver for all probes
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-1720
In Commercial Distribution

  • 04953170355684 ()


  • General-purpose ultrasound imaging system
SST TWIST DRILL, AO TYPE, 3.2mm DIA. X 120mm
Microaire Surgical Instruments LLC
8053-031
In Commercial Distribution

  • 00847399005243 ()

  • Outer Diameter: 3.2 Millimeter
  • Length: 120 Millimeter


  • Cannulated surgical drill bit, single-use
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