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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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No Description
DETAX GmbH
02487
In Commercial Distribution

  • EDET024871 ()


  • Earmould impression material
No Description
DETAX GmbH
02295
In Commercial Distribution

  • EDET022951 ()


  • Earmould impression material
No Description
DETAX GmbH
02081
In Commercial Distribution

  • EDET020811 ()


  • Earmould, custom-made
No Description
SURETEK MEDICAL
AR-6570
In Commercial Distribution

  • B390AR65701 ()


  • Bone access cannula
No Description
SURETEK MEDICAL
AR-6535
In Commercial Distribution

  • B390AR65351 ()


  • Bone access cannula
No Description
SURETEK MEDICAL
57SR0220
In Commercial Distribution

  • B39057SR02201 ()


  • Burring power tool attachment
osteo-WEDGE Temporary Tack, 2.4mm x 12mm. Non-sterile single use (disposable) accessory for use with the osteo-WEDGE Opening Wedge Bone Locking Plate System. The osteo-WEDGE Opening Wedge Bone Locking Plate System is used for adult and transitional adolescent (18 to 21 years old) patients for the purpose of stabilization and/or correction of angular deviations within an individual bone or in between two adjacent bones in the foot, such as opening wedge osteotomy for first metatarsal cuneiform joint deviations.
Gramedica
GM-100-12
In Commercial Distribution

  • M621OW24TT12MM0 ()

  • 2.4mm x 12mm
OW2.4TT-12MM

  • Orthopaedic fixation plate, non-bioabsorbable
No Description
Conformis, Inc.
PAT011441101
In Commercial Distribution

  • M572PAT0114411011 ()

  • 44MM X 11MM
PAT0114411

  • Polyethylene patella prosthesis
Rat Tooth 2 x 3 Tip
ORANGE SURGICAL INSTRUMENTS, LLC
OSRT
In Commercial Distribution

  • B354OSRT0 ()
OSRT

  • Endoscopic electrosurgical electrode, monopolar, single-use
8mm Plug x 3M Cable Disposable
ORANGE SURGICAL INSTRUMENTS, LLC
OSMCD8MMX3M
In Commercial Distribution

  • B35400 ()
  • B354OSMCD8MMX3M9 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use
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