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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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DENALI® Spinal System - 10888857283459

Handle Teardrop 1/4 in. Quick Connect
K2M, INC.
SP-381
In Commercial Distribution

  • 10888857283459 ()
SP-381

  • Surgical instrument handle, non-torque-limiting

MESA Small Stature Spinal System - 10888857186941

In Situ Bender (Right) MESA Rail ™
K2M, INC.
K2-30-2066-01
In Commercial Distribution

  • 10888857186941 ()
K2-30-2066-01

  • Orthopaedic prosthesis implantation positioning instrument, reusable

MESA Small Stature Spinal System - 10888857186934

In Situ Bender (Left) MESA Rail ™
K2M, INC.
K2-30-2065-01
In Commercial Distribution

  • 10888857186934 ()
K2-30-2065-01

  • Orthopaedic prosthesis implantation positioning instrument, reusable

DENALI MI Spinal System - 10888857185494

NiTi Guidewire Size .044 X 20.5 IN
K2M, INC.
K2-10-2239-01
In Commercial Distribution

  • 10888857185494 ()
K2-10-2239-01

  • Internal spinal fixation procedure kit, single-use

HU-FRIEDY - 10889950042912

CIGFTMINI 1 COND/AB-1 PLASTIC FILLING IN
HU-FRIEDY MFG. CO., LLC
CI5116
Not in Commercial Distribution

  • 10889950042912 ()
CI5116

  • Dental restoration carver, resin

HU-FRIEDY - 10889950016272

Vascular Perma Sharp Needle Holder 7 in
HU-FRIEDY MFG. CO., LLC
NH5084
In Commercial Distribution

  • 10889950016272 ()
NH5084

  • Suturing needle holder, reusable

IMS - 10889950056636

Hinged 8-inst, Yellow. 2 IM1005 in Lid
HU-FRIEDY MFG. CO., LLC
IM5085HAW2
In Commercial Distribution

  • 10889950056636 ()
IM5085HAW2

  • Device sterilization/disinfection container, reusable

IMS - 10889950071608

OS, 20-inst, Yellow, 2AW, FM in acc
HU-FRIEDY MFG. CO., LLC
IMOS205A2F
In Commercial Distribution

  • 10889950071608 ()
IMOS205A2F

  • Device sterilization/disinfection container, reusable

IMS - 10889950071493

OS, 20-inst, Pink, 2AW, FM in acc
HU-FRIEDY MFG. CO., LLC
IMOS2010AF
In Commercial Distribution

  • 10889950071493 ()
IMOS2010AF

  • Device sterilization/disinfection container, reusable

IMS - 10889950059125

5-Inst. Sig, Ylw, Posted AW in Lid
HU-FRIEDY MFG. CO., LLC
IM6055LAW
In Commercial Distribution

  • 10889950059125 ()
IM6055LAW

  • Device sterilization/disinfection container, reusable
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