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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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K WIRE TROCAR PIN ROUND with ROUND END 500MM X 1.3MM
SONTEC INSTRUMENTS, INC.
1106-717
In Commercial Distribution

  • B09911067170 ()
  • 00192896001732 ()
  • 10192896001739 ()
  • 20192896001736 ()

  • Length: 500 Millimeter
  • Width: 1.3 Millimeter
1106-717

  • Orthopaedic bone pin, non-bioabsorbable
6+ CARTRIDGE
ABBOTT POINT OF CARE INC.
03P80-25
In Commercial Distribution

  • 10054749000088 ()
  • 00054749000081 ()
03P80-25

  • Potassium (K+) electrode IVD
  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent
  • Sodium (Na+) electrode IVD
  • Urea IVD, reagent
  • Chloride (Cl-) electrode IVD
Golden K File SS-Size #15-40 (6 files) 25mm Length
GoldenDent
GKAP
In Commercial Distribution

  • 00850011211540 ()
GKAP

  • Manual endodontic file/rasp, reusable
iLightPro - Powered Laser Surgical Instrument - FDA 510(k) K190938
MDElite Laser and Aesthetic, LLC
iLightPro
In Commercial Distribution

  • 00860007876820 ()


  • General/multiple surgical diode laser system
LIEBERMAN OPEN WIRE SPECULUM, 15MM OPEN BLADE, K WIRE
HNM STAINLESS, LLC.
HNM-1-60-2003
In Commercial Distribution

  • 00842962144107 ()
HNM-1-60-2003

  • Eyelid speculum, reusable
M800P-S/K, KaVo Backend, Standard Head, Triple Spray, Direct-LED
Beyes Dental Canada Inc
HP3035P
In Commercial Distribution

  • 00628504370803 ()


  • Dental power tool system handpiece, pneumatic
Dynasty® Dual Mobility Trial Liner Group K 56mm
Microport Orthopedics Inc.
33DMGK56
In Commercial Distribution

  • M68433DMGK561 ()
  • 00192629235861 ()
33DMGK56

  • Acetabulum prosthesis trial, prefabricated, reusable
Dynasty® 15DG Poly Trial Liner Group K 44mm
Microport Orthopedics Inc.
3304LK44
In Commercial Distribution

  • M6843304LK441 ()
  • 00192629364875 ()
3304LK44

  • Joint prosthesis implantation kit, reusable
Dynasty® Std Poly Trial Liner Group K 44mm
Microport Orthopedics Inc.
3304GK44
In Commercial Distribution

  • M6843304GK441 ()
  • 00192629364837 ()
3304GK44

  • Joint prosthesis implantation kit, reusable
REFLECTION XLPE 36 0 DEG LATERALIZED +4 70-76 K
Smith & Nephew, Inc.
71333499
In Commercial Distribution

  • 03596010552983 ()
71333499

  • Non-constrained polyethylene acetabular liner
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