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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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Sterile disposable microkeratome blade, for use on the MED-LOGICS, Inc. ML7061 Metal Head
MED LOGICS INC
ML7061 (+10)
In Commercial Distribution

  • 10850724001176 ()
  • 00850724001179 ()
ML7061 (+10)

  • Keratome blade, single-use
Sterile disposable microkeratome blade, for use on the Moria® M2 Microkeratome, Sample
MED LOGICS INC
ML7050 (-10)
In Commercial Distribution

  • 00850724001155 ()
  • 10850724001152 ()
ML7050 (-10)

  • Keratome blade, single-use
Sterile disposable microkeratome blade, for use on the Moria® C-B Microkeratome, Sample
MED LOGICS INC
ML7020 (+10)
In Commercial Distribution

  • 00850724001124 ()
  • 10850724001121 ()
ML7020 (+10)

  • Keratome blade, single-use
Sterile disposable microkeratome blade, for use on the MED-LOGICS ML7™ Microkeratome, Sample
MED LOGICS INC
ML7100 (-10)
In Commercial Distribution

  • 00850724001094 ()
  • 10850724001091 ()
ML7100 (-10)

  • Keratome blade, single-use
Sterile disposable microkeratome blade, for use on the Nidek® MK-2000 Keratome System, Sample
MED LOGICS INC
ML7030 (-10)
In Commercial Distribution

  • 00850724001032 ()
  • 10850724001039 ()
ML7030 (-10)

  • Keratome blade, single-use
No Description
W.H. Holden, Inc.
10-5210
In Commercial Distribution

  • D9281052100 ()


  • Bone file/rasp, reciprocating, single-use
Drill Guide
NOVASTEP
XDG01001
In Commercial Distribution

  • 03700879500485 ()
XDG01001

  • General internal orthopaedic fixation system implantation kit
Forceps
NOVASTEP
XFP03001
In Commercial Distribution

  • 03700879500614 ()
XFP03001

  • General internal orthopaedic fixation system implantation kit
HyProCure Sizer 10. Reusable instrument, for use with the HyProCure Sinus Tarsi Implant System. Indications: HyProCure is a talotarsal stabilization device used in the treatment of talotarsal dislocation and resulting sequela. The implant is designed to stabilize the talus on the tarsal mechanism to prevent excessive anterior, and/or medial, and/or plantarflexion of the talus on the tarsal mechanism, while allowing normal talotarsal joint motion.
Gramedica
CP15-10-FG
In Commercial Distribution

  • M621CP1510FG0 ()
CP15-10-FG

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Provides relief space for adhesive material and prevent overflow of cement into function areas of the attachment when connecting elements of implant attachment components. Made from silicone rubber.
STERNGOLD DENTAL LLC
909013
In Commercial Distribution

  • 00841549118197 ()


  • Dental impression spacer
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