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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LOMBARDI FEMORAL TIBIAL SPEADERS SMALL
ELMED INCORPORATED
ST231876
In Commercial Distribution

  • 00842180195875 ()
ST231876

  • Arthroscopic surgical procedure kit, non-medicated, reusable
ANGIO DRAPE - FEMORAL/RADIAL, 1-EACH
Microtek Medical LLC
1
In Commercial Distribution

  • 50748426113250 ()
  • 00748426113255 ()


  • Angiographic drape
ANGIO DRAPE - FEMORAL/RADIAL, 1-EACH
Microtek Medical LLC
1
In Commercial Distribution

  • 50748426108690 ()
  • 00748426108695 ()


  • Angiographic drape
ANGIO DRAPE - FEMORAL/RADIAL, 1-EACH
Microtek Medical LLC
1
In Commercial Distribution

  • 50748426108164 ()
  • 00748426108169 ()


  • Angiographic drape
ANGIO DRAPE - INTRAJUGULAR/FEMORAL, 1-EACH
Microtek Medical LLC
1
In Commercial Distribution

  • 50748426098472 ()
  • 00748426098477 ()


  • Angiographic drape
HEAD, FEMORAL COCR 22MM, +4MM
Encore Medical, L.P.
400-01-222
In Commercial Distribution

  • 00888912075640 ()


  • Metallic femoral head prosthesis
HEAD, FEMORAL COCR 22MM NEUTRAL
Encore Medical, L.P.
400-01-221
In Commercial Distribution

  • 00888912075626 ()


  • Metallic femoral head prosthesis
AK3 Femoral Instruments Pan Insert
Omni Life Science, Inc.
KS-90076-IN
In Commercial Distribution

  • 00841690195108 ()
KS-90076-IN

  • Instrument tray, reusable
Posterior Up Femoral Sizing Guide
Omni Life Science, Inc.
KS-72001
In Commercial Distribution

  • 00841690189909 ()
KS-72001

  • Joint prosthesis implantation kit, reusable
TIBIA FIRST FEMORAL INSTRUMENTS pan
Omni Life Science, Inc.
KS-99190
In Commercial Distribution

  • 00841690188926 ()
KS-99190

  • Instrument tray, reusable
Classic Femoral Instrument Pan Insert
Omni Life Science, Inc.
KS-99918-IN
In Commercial Distribution

  • 00841690188742 ()
KS-99918-IN

  • Instrument tray, reusable
FEMORAL DISTAL CUT GUIDE - LEFT
Omni Life Science, Inc.
XK-00230
In Commercial Distribution

  • 00841690187080 ()
XK-00230

  • Joint prosthesis implantation kit, reusable
FEMORAL DISTAL CUT GUIDE - RIGHT
Omni Life Science, Inc.
XK-00231
In Commercial Distribution

  • 00841690187073 ()
XK-00231

  • Joint prosthesis implantation kit, reusable
AK3 Distal Femoral Cutting Block
Omni Life Science, Inc.
XK-05662
In Commercial Distribution

  • 00841690186762 ()
XK-05662

  • Joint prosthesis implantation kit, reusable
Femoral Sizer, Stylus Assy, Right
Omni Life Science, Inc.
KI-CEQP0-12-21
In Commercial Distribution

  • 00841690185307 ()
KI-CEQP0-12-21

  • Orthopaedic fixation implant alignment tool
TIBIA FIRST FEMORAL INSTRUMENTS pan
Omni Life Science, Inc.
KS-99189
In Commercial Distribution

  • 00841690125303 ()
KS-99189

  • Instrument tray, reusable
MIS Femoral Distal Cut Guide
Omni Life Science, Inc.
WS-10052
In Commercial Distribution

  • 00841690121145 ()
WS-10052

  • Joint prosthesis implantation kit, reusable
MIS Femoral Distal Block Holder
Omni Life Science, Inc.
WS-10016
In Commercial Distribution

  • 00841690121138 ()
WS-10016

  • Joint prosthesis implantation kit, reusable
MIS Femoral Distal Cutting Block
Omni Life Science, Inc.
WS-10015
In Commercial Distribution

  • 00841690121121 ()
WS-10015

  • Joint prosthesis implantation kit, reusable
Antegrade Targeting Module, Femoral Nail
ARTHREX, INC.
AR-9097-27
In Commercial Distribution

  • 00888867445208 ()
AR-9097-27

  • Orthopaedic implant aiming arm
AK3 Femoral Sizing/Alignment Guide
Omni Life Science, Inc.
KS-90022
In Commercial Distribution

  • 00841690189756 ()
KS-90022

  • Joint prosthesis implantation kit, reusable
FOOTPRINT FEMORAL ACL GUIDE, LEFT
ARTHREX, INC.
AR-1510FL
In Commercial Distribution

  • 00888867018297 ()
AR-1510FL

  • Surgical drill guide, reusable
IBALANCE TKA, FEMORAL PEG DRILL
ARTHREX, INC.
AR-613-70
In Commercial Distribution

  • 00888867116795 ()
AR-613-70

  • Surgical drill guide, reusable
iBALANCE TKA, FEMORAL ADJUSTMENT BLOCK
ARTHREX, INC.
AR-613-47
In Commercial Distribution

  • 00888867116481 ()
AR-613-47

  • Surgical drill guide, reusable
iBALANCE TKA, FEMORAL ALIGNMENT GUIDE
ARTHREX, INC.
AR-613-42
In Commercial Distribution

  • 00888867116436 ()
AR-613-42

  • Orthopaedic fixation implant alignment tool
iBALANCE TKA, FEMORAL SIZING STYLUS
ARTHREX, INC.
AR-613-24
In Commercial Distribution

  • 00888867116238 ()
AR-613-24

  • Orthopaedic fixation implant alignment tool
IBALANCE TKA, FEMORAL HOLE SAW
ARTHREX, INC.
AR-603-73
In Commercial Distribution

  • 00888867112117 ()
AR-603-73

  • Suturing unit, single-use
PACEMAKER/ANGIOGRAPHY DRAPE - FEMORAL, 1-EACH
Microtek Medical LLC
1
In Commercial Distribution

  • 50748426070584 ()
  • 00748426070589 ()


  • Patient surgical drape, single-use
EMPOWR 3D, FEMORAL TRIAL, 2R
Encore Medical, L.P.
800-05-313
In Commercial Distribution

  • 00888912168694 ()


  • Surgical implant template, reusable
EMPOWR 3D, FEMORAL TRIAL, 1R
Encore Medical, L.P.
800-05-312
In Commercial Distribution

  • 00888912168687 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
EMPOWR 3D, FEMORAL TRIAL, 2L
Encore Medical, L.P.
800-05-302
In Commercial Distribution

  • 00888912168588 ()


  • Surgical implant template, reusable
EMPOWR 3D, FEMORAL TRIAL, 1L
Encore Medical, L.P.
800-05-301
In Commercial Distribution

  • 00888912168571 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
ACF, Distal Femoral Cutting block
ARTHREX, INC.
SP-613-44
In Commercial Distribution

  • 00888867285651 ()
SP-613-44

  • Joint prosthesis implantation kit, reusable
iBalance TKA Locking Femoral Impactor
ARTHREX, INC.
AR-613-49NT
Not in Commercial Distribution

  • 00888867284364 ()
AR-613-49NT

  • Orthopaedic implant impactor, reusable
CASE,HIP FEMORAL #1 REAMER
DJO, LLC
803-99-001
In Commercial Distribution

  • 00888912105439 ()


  • Orthopaedic femur reamer trial
HEAD, FEMORAL, COCR 28/+10.5MM
Encore Medical, L.P.
497-28-105
In Commercial Distribution

  • 00888912087285 ()


  • Metallic femoral head prosthesis
HEAD, FEMORAL , COCR 28MM NEUTRAL
Encore Medical, L.P.
497-28-000
In Commercial Distribution

  • 00888912087254 ()


  • Metallic femoral head prosthesis
Femoral Head, 40mm +4mm (L)
ORTHOMEDFLEX LLC
111152643
In Commercial Distribution

  • M7161111526430 ()
111-152-643

  • Ceramic femoral head prosthesis
Femoral Head, 40mm +0mm (M)
ORTHOMEDFLEX LLC
111152642
In Commercial Distribution

  • M7161111526420 ()
111-152-642

  • Ceramic femoral head prosthesis
Femoral Head, 40mm -4mm (S)
ORTHOMEDFLEX LLC
111152641
In Commercial Distribution

  • M7161111526410 ()
111-152-641

  • Ceramic femoral head prosthesis
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