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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Alteon Highly Polished Femoral Stem
Exactech, Inc.
190-60-14
In Commercial Distribution

  • 10885862528414 ()

  • Standard Offset
  • Size 14
190-60-14

  • Uncoated femoral stem prosthesis, one-piece
TRIAL, UNIVERSAL FEMORAL, SIZE 4
Exactech, Inc.
02-029-15-1040
In Commercial Distribution

  • 10885862523211 ()

  • SIZE 4
02-029-15-1040

  • Knee femur prosthesis trial, reusable
TRIAL, UNIVERSAL FEMORAL, SIZE 1.5
Exactech, Inc.
02-029-15-1015
In Commercial Distribution

  • 10885862523167 ()

  • SIZE 1.5
02-029-15-1015

  • Knee femur prosthesis trial, reusable
Femoral INTRAFIXSystem Positioner Replacement Screw
DEPUY MITEK, LLC
254690
In Commercial Distribution

  • 10886705013692 ()
254690

  • Orthopaedic graft inserter, reusable
Femoral INTRAFIX Hex Driver 21mm
DEPUY MITEK, LLC
254671
In Commercial Distribution

  • 10886705013531 ()
254671

  • Surgical screwdriver, reusable
STRL FRACTURED HIP FEMORAL PK
Cardinal Health 200, LLC
SOPHDFFAGO
In Commercial Distribution

  • 50887488262664 ()
  • 10887488262666 ()
SOPHDFFAGO

  • Orthopaedic surgical procedure kit, non-medicated, single-use
STERILE IR FEMORAL PREP PACK
Cardinal Health 200, LLC
SBA13FPLCA
In Commercial Distribution

  • 50887488335030 ()
  • 10887488335032 ()
SBA13FPLCA

  • Cardiothoracic surgical procedure kit, medicated, single-use
STERILE FEMORAL EP PHC TRAY
Cardinal Health 200, LLC
SAN23FEPHB
In Commercial Distribution

  • 50887488320838 ()
  • 10887488320830 ()
SAN23FEPHB

  • Cardiothoracic surgical procedure kit, medicated, single-use
PARTNER FEMORAL ADD A PACK
Cardinal Health 200, LLC
SOP51FAUSF
In Commercial Distribution

  • 50887488387671 ()
  • 10887488387673 ()
SOP51FAUSF

  • Angiography kit
STERILE OPEN FEMORAL DRAPE PK
Cardinal Health 200, LLC
SBA13OFDHB
In Commercial Distribution

  • 50887488385776 ()
  • 10887488385778 ()
SBA13OFDHB

  • Patient surgical drape, single-use
Posterior Up Femoral Sizing Guide
Omni Life Science, Inc.
KS-72001
In Commercial Distribution

  • 00841690189909 ()
KS-72001

  • Joint prosthesis implantation kit, reusable
AK3 Femoral Sizing/Alignment Guide
Omni Life Science, Inc.
KS-90022
In Commercial Distribution

  • 00841690189756 ()
KS-90022

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

  • 00841690188742 ()
KS-99918-IN

  • Instrument tray, 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
ARC Femoral Stem Size 0
Omni Life Science, Inc.
HC-21000
In Commercial Distribution

  • 00841690119654 ()
HC-21000

  • Coated hip femur prosthesis, modular
K1 Femoral Stem, Size 0
Omni Life Science, Inc.
HC-00000
In Commercial Distribution

  • 00841690118909 ()
HC-00000

  • Coated hip femur prosthesis, modular
Femoral CoCr Head 28mm +10.5mm
Omni Life Science, Inc.
302810
In Commercial Distribution

  • 00841690100379 ()
302810

  • Metallic femoral head prosthesis
K1 Femoral Stem, Size 12
Omni Life Science, Inc.
HC-00120
In Commercial Distribution

  • 00841690100287 ()
HC-00120

  • Coated hip femur prosthesis, modular
K1 Femoral Stem, Size 10
Omni Life Science, Inc.
HC-00100
In Commercial Distribution

  • 00841690100225 ()
HC-00100

  • Coated hip femur prosthesis, modular
K1 Femoral Stem, Size 8
Omni Life Science, Inc.
HC-00080
In Commercial Distribution

  • 00841690100164 ()
HC-00080

  • Coated hip femur prosthesis, modular
K1 Femoral Stem, Size 7
Omni Life Science, Inc.
HC-00070
In Commercial Distribution

  • 00841690100133 ()
HC-00070

  • Coated hip femur prosthesis, modular
K1 Femoral Stem, Size 6
Omni Life Science, Inc.
HC-00060
In Commercial Distribution

  • 00841690100119 ()
HC-00060

  • Coated hip femur prosthesis, modular
K1 Femoral Stem, Size 5
Omni Life Science, Inc.
HC-00050
In Commercial Distribution

  • 00841690100096 ()
HC-00050

  • Coated hip femur prosthesis, modular
K1 Femoral Stem, Size 4
Omni Life Science, Inc.
HC-00040
In Commercial Distribution

  • 00841690100072 ()
HC-00040

  • Coated hip femur prosthesis, modular
K1 Femoral stem, size 3
Omni Life Science, Inc.
HC-00030
In Commercial Distribution

  • 00841690100058 ()
HC-00030

  • Coated hip femur prosthesis, modular
K1 Femoral Stem, Size 2
Omni Life Science, Inc.
HC-00020
In Commercial Distribution

  • 00841690100034 ()
HC-00020

  • Coated hip femur prosthesis, modular
K1 Femoral Stem, Size 1
Omni Life Science, Inc.
HC-00010
In Commercial Distribution

  • 00841690100010 ()
HC-00010

  • Coated hip femur prosthesis, modular
STERILE SLP FEMORAL ANGIO PACK
Cardinal Health 200, LLC
SAN30SLPRA
In Commercial Distribution

  • 50887488481140 ()
  • 10887488481142 ()
SAN30SLPRA

  • Angiography kit
TIBIA FIRST FEMORAL INSTRUMENTS pan
Omni Life Science, Inc.
KS-99190
In Commercial Distribution

  • 00841690188926 ()
KS-99190

  • 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 CoCr Head 36mm +10.5mm
Omni Life Science, Inc.
303610
In Commercial Distribution

  • 00841690103172 ()
303610

  • Metallic femoral head prosthesis
Femoral CoCr Head 32mm +10.5mm
Omni Life Science, Inc.
303210
In Commercial Distribution

  • 00841690103127 ()
303210

  • Metallic femoral head prosthesis
K2 Femoral Stem, Size 12
Omni Life Science, Inc.
130012
In Commercial Distribution

  • 00841690102557 ()
130012

  • Coated hip femur prosthesis, modular
K2 Femoral Stem, Size 11
Omni Life Science, Inc.
130011
In Commercial Distribution

  • 00841690102540 ()
130011

  • Coated hip femur prosthesis, modular
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