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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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Arthrex® - 10888867116549

iBALANCE TKA, TROCAR PIN SMOOTH
ARTHREX, INC.
AR-613-50
In Commercial Distribution

  • 00888867116542 ()
  • 10888867116549 ()
AR-613-50

  • Orthopaedic fixation implant alignment tool

Arthrex® - 10888867088082

GUIDE PIN W/SUTURE EYE 2.4MM
ARTHREX, INC.
AR-1297L
In Commercial Distribution

  • 10888867088082 ()
  • 00888867088085 ()
AR-1297L

  • Fluted surgical drill bit, single-use

Arthrex® - 10888867088075

GUIDE PIN W/SUTURE EYE 1.7MM
ARTHREX, INC.
AR-1297
In Commercial Distribution

  • 10888867088075 ()
  • 00888867088078 ()
AR-1297

  • Orthopaedic intraoperative positioning pin, single-use

Arthrex® - 10888867056777

GUIDE WIRE W/TROCAR TIP, THREADED, 12"
ARTHREX, INC.
AR-8967KT-12
In Commercial Distribution

  • 00888867056770 ()
  • 10888867056777 ()
AR-8967KT-12

  • Fluted surgical drill bit, single-use

Arthrex® - 10888867056760

GUIDE WIRE W/TROCAR TIP, THREADED, 8"
ARTHREX, INC.
AR-8967KT
In Commercial Distribution

  • 00888867056763 ()
  • 10888867056760 ()
AR-8967KT

  • Fluted surgical drill bit, single-use

Arthrex® - 10888867056753

G-WIRE W/TRCR TIP,NON-THRDED,12"
ARTHREX, INC.
AR-8967K-12
In Commercial Distribution

  • 00888867056756 ()
  • 10888867056753 ()
AR-8967K-12

  • Fluted surgical drill bit, single-use

Arthrex® - 10888867056746

G-WIRE W/TRCR TIP .094"X8" (2.4X 200MM)
ARTHREX, INC.
AR-8967K
In Commercial Distribution

  • 00888867056749 ()
  • 10888867056746 ()
AR-8967K

  • Fluted surgical drill bit, single-use

Arthrex® - 10888867055800

GDWIRE W/TRCR TIP .078"X8" (2MMX 200MM)
ARTHREX, INC.
AR-8956K-01
In Commercial Distribution

  • 10888867055800 ()
  • 00888867055803 ()
AR-8956K-01

  • Fluted surgical drill bit, single-use

Arthrex® - 10888867052458

THRDED G-WIRE W/TRCR TIP,Ø 1.35MM
ARTHREX, INC.
AR-8943-38
In Commercial Distribution

  • 00888867052451 ()
  • 10888867052458 ()
AR-8943-38

  • Orthopaedic intraoperative positioning pin, single-use

Arthrex® - 10888867049977

THRDED GDWIRE W/TRCR TIP,.045"X3.75"
ARTHREX, INC.
AR-8933KT
In Commercial Distribution

  • 00888867049970 ()
  • 10888867049977 ()
AR-8933KT

  • Orthopaedic intraoperative positioning pin, single-use

Arthrex® - 10888867038704

iBALANCE TKA, THREADED PIN, HEADED
ARTHREX, INC.
AR-603-72
In Commercial Distribution

  • 00888867038707 ()
  • 10888867038704 ()
AR-603-72

  • Suturing unit, single-use

Arthrex® - 10888867034836

GUIDEWIRE FOR BIO- COMPRESSION SCREW
ARTHREX, INC.
AR-5025K
In Commercial Distribution

  • 00888867034839 ()
  • 10888867034836 ()
AR-5025K

  • Orthopaedic intraoperative positioning pin, single-use

Arthrex® - 10888867010717

OSTEOTOMY GUIDE PIN, 3.0MM
ARTHREX, INC.
AR-13303-3.0
In Commercial Distribution

  • 10888867010717 ()
  • 00888867010710 ()
AR-13303-3.0

  • Fluted surgical drill bit, single-use

Arthrex® - 10888867010694

OSTEOTOMY GUIDE PIN, 2.4MM
ARTHREX, INC.
AR-13303-2.4
In Commercial Distribution

  • 10888867010694 ()
  • 00888867010697 ()
AR-13303-2.4

  • Fluted surgical drill bit, single-use

Arthrex® - 10888867010243

GUIDE WIRE, 0.86MM
ARTHREX, INC.
AR-13240K
In Commercial Distribution

  • 10888867010243 ()
  • 00888867010246 ()
AR-13240K

  • Orthopaedic intraoperative positioning pin, single-use

Arthrex® - 10888867007243

BONE-TENDON-BONE GRAFT INSERTER
ARTHREX, INC.
AR-1298
In Commercial Distribution

  • 10888867007243 ()
  • 00888867007246 ()
AR-1298

  • Orthopaedic graft inserter, reusable

Arthrex® - 10888867241401

End Cap, Screws
ARTHREX, INC.
AR-8964-22
In Commercial Distribution

  • 00888867241404 ()
  • M150AR8964220 ()
  • 10888867241401 ()
AR-8964-22

  • External orthopaedic fixation system, single-use

Arthrex® - 10888867233857

Ø1.35MM GUIDE WIRE, DUAL TROCAR
ARTHREX, INC.
AR-5050-01
In Commercial Distribution

  • 00888867233850 ()
  • 10888867233857 ()
AR-5050-01

  • Fluted surgical drill bit, reusable

Arthrex® - 10888867230801

Guide Wire, 1.35mm, Trocar Tip
ARTHREX, INC.
AR-8963-04
In Commercial Distribution

  • 00888867230804 ()
  • 10888867230801 ()
AR-8963-04

  • Fluted surgical drill bit, single-use

Arthrex® - 10888867207216

Guide Wire, Ø.090 x 4"
ARTHREX, INC.
AR-7011
In Commercial Distribution

  • 00888867207219 ()
  • 10888867207216 ()
AR-7011

  • Orthopaedic intraoperative positioning pin, single-use

Arthrex® - 10888867054407

G-WIRE W/DBL TRCR TIP,.045"X6.84"
ARTHREX, INC.
AR-8950-06
In Commercial Distribution

  • 00888867054400 ()
  • 10888867054407 ()
AR-8950-06

  • Fluted surgical drill bit, single-use

Arthrex® - 10888867054087

G-WIRE W/TRCR TIP .078"X5.91"(2MMX150MM)
ARTHREX, INC.
AR-8945K
In Commercial Distribution

  • 00888867054080 ()
  • 10888867054087 ()
AR-8945K

  • Orthopaedic intraoperative positioning pin, single-use

Arthrex® - 10888867052113

GUIDE WIRE, TROCAR TIP, 1.35 MM
ARTHREX, INC.
AR-8943-01
In Commercial Distribution

  • 00888867052116 ()
  • 10888867052113 ()
AR-8943-01

  • Suturing unit, single-use

Arthrex® - 10888867049953

GUIDE WIRE, .045" X 5.91"
ARTHREX, INC.
AR-8933K
In Commercial Distribution

  • 00888867049956 ()
  • 10888867049953 ()
AR-8933K

  • Orthopaedic intraoperative positioning pin, single-use

Arthrex® - 10888867049021

GDWIRE,T-ROPE SYNDESMOSIS REPR KIT
ARTHREX, INC.
AR-8920P
In Commercial Distribution

  • 00888867049024 ()
  • 10888867049021 ()
AR-8920P

  • Fluted surgical drill bit, single-use

Arthrex® - 10888867046174

GDWIRE,0.86MM W/LASER LINE,THRDED,SS
ARTHREX, INC.
AR-8737-22
In Commercial Distribution

  • 00888867046177 ()
  • 10888867046174 ()
AR-8737-22

  • Fluted surgical drill bit, single-use

Arthrex® - 10888867046167

GUIDEWIRE, 0.86MM W/ LASER LINE, SS
ARTHREX, INC.
AR-8737-21
In Commercial Distribution

  • 00888867046160 ()
  • 10888867046167 ()
AR-8737-21

  • Suturing unit, single-use

Arthrex® - 10888867046006

THD GDWIRE W TRCR TIP,.045" W/LASER LINE
ARTHREX, INC.
AR-8737-05
In Commercial Distribution

  • 00888867046009 ()
  • 10888867046006 ()
AR-8737-05

  • Suturing unit, single-use

Arthrex® - 10888867045979

THRDED G-WIRE W/TRCR TIP,Ø 1.35MM
ARTHREX, INC.
AR-8737-02
In Commercial Distribution

  • 00888867045972 ()
  • 10888867045979 ()
AR-8737-02

  • Suturing unit, single-use

Arthrex® - 10888867044828

GUIDE WIRE, 1MM (.039")
ARTHREX, INC.
AR-8708K
In Commercial Distribution

  • 00888867044821 ()
  • 10888867044828 ()
AR-8708K

  • Suturing unit, single-use

Arthrex® - 10888867033464

PROSTOP PLUS GUIDE WIRE, .054" DIAMETER
ARTHREX, INC.
AR-4206
In Commercial Distribution

  • 00888867033467 ()
  • 10888867033464 ()
AR-4206

  • Fluted surgical drill bit, single-use

Arthrex® - 10888867033327

GUIDE WIRE, 0.078" DIA
ARTHREX, INC.
AR-4202
In Commercial Distribution

  • 00888867033320 ()
  • 10888867033327 ()
AR-4202

  • Orthopaedic intraoperative positioning pin, single-use

Arthrex® - 10888867027166

PERC PINNING G-WIRE,DISP
ARTHREX, INC.
AR-2524
In Commercial Distribution

  • 00888867027169 ()
  • 10888867027166 ()
AR-2524

  • Fluted surgical drill bit, single-use

Arthrex® - 10888867018652

GUIDE WIRE .041 DIAMETER
ARTHREX, INC.
AR-1530K
In Commercial Distribution

  • 00888867018655 ()
  • 10888867018652 ()
AR-1530K

  • Orthopaedic intraoperative positioning pin, single-use

2.6MM LACTONAIL INSERTER TIP - 00880304467132

No Description
Biomet Orthopedics, LLC
948947
In Commercial Distribution

  • 00880304467132 ()
948947

  • Suturing unit, reusable

1.6/2MM LACTONAIL PUSHER - 00880304467125

No Description
Biomet Orthopedics, LLC
948945
In Commercial Distribution

  • 00880304467125 ()
948945

  • Orthopaedic implant driver

ARCOS MODULAR REVISION SYSTEM - 00880304484412

No Description
Biomet Orthopedics, LLC
31-301870
In Commercial Distribution

  • 00880304484412 ()
31-301870

  • Surgical instrument handle, non-torque-limiting

Ratchet Handle - 00880304412347

No Description
Biomet Orthopedics, LLC
909733
In Commercial Distribution

  • 00880304412347 ()
909733

  • Surgical instrument handle, non-torque-limiting

Aimer Handle - 00880304411777

No Description
Biomet Orthopedics, LLC
909623
In Commercial Distribution

  • 00880304411777 ()
909623

  • Surgical instrument handle, non-torque-limiting

FOLDING TWIST DRILL HOLDER ONLY - 00880304397705

No Description
Biomet Orthopedics, LLC
596230
In Commercial Distribution

  • 00880304397705 ()
596230

  • Surgical instrument handle, non-torque-limiting
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