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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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BONE CUTR,HL 4.2MMX 19CM
ARTHREX, INC.
AR-6420BC
In Commercial Distribution

  • 10888867039169 ()
  • 00888867039162 ()
AR-6420BC

  • Arthroscopic shaver system, electrically-powered
BURR, ROUND, HL, 8 FLUTE, 4.0MM X 19CM
ARTHREX, INC.
AR-6400RBE
In Commercial Distribution

  • 10888867039121 ()
  • 00888867039124 ()
AR-6400RBE

  • Arthroscopic shaver system, electrically-powered
IRRIGATION SHEATH ADAPTER, DYONICS
ARTHREX, INC.
AR-6223
In Commercial Distribution

  • 10888867039046 ()
  • 00888867039049 ()
AR-6223

  • Surgical irrigation tubing set, single-use
TUBING, EXTENSION 6FT. (20-BOX)
ARTHREX, INC.
AR-6220
In Commercial Distribution

  • 00888867039032 ()
  • M150AR62201 ()
  • 10888867039039 ()
AR-6220

  • Cardiac ablation system irrigation tubing set
Y-INFLOW TUBING, 7.0MM
ARTHREX, INC.
AR-6200
In Commercial Distribution

  • 10888867039008 ()
  • 00888867039001 ()
AR-6200

  • Cardiac ablation system irrigation tubing set
iBALANCE, HANDLE, QUICK CONNECT
ARTHREX, INC.
AR-613-8
In Commercial Distribution

  • 00888867038998 ()
AR-613-8

  • Orthopaedic inorganic implant inserter/extractor, reusable
90 DEG TIGHT CURVE QUICKPASS LASSO
ARTHREX, INC.
AR-6068-90T
In Commercial Distribution

  • 00888867038974 ()
AR-6068-90T

  • Suturing unit, single-use
45 DEG CURVE RIGHT, FASTPASS LASSO
ARTHREX, INC.
AR-6068-45R
In Commercial Distribution

  • 00888867038936 ()
AR-6068-45R

  • Suturing unit, single-use
30 DEG STRAIGHT QUICKPASS LASSO
ARTHREX, INC.
AR-6068-30
In Commercial Distribution

  • 00888867038912 ()
AR-6068-30

  • Suturing unit, single-use
25 DEG TIGHT CURVE LEFT, QUICKPASS LASSO
ARTHREX, INC.
AR-6068-25TL
In Commercial Distribution

  • 00888867038899 ()
AR-6068-25TL

  • Suturing unit, single-use
QUICKPASS LASSO WIRE
ARTHREX, INC.
AR-6068-01
In Commercial Distribution

  • 10888867038889 ()
  • 00888867038882 ()
AR-6068-01

  • Suturing unit, single-use
iBALANCE TKA, LMR INSTRUMENT CASE
ARTHREX, INC.
AR-605-C
In Commercial Distribution

  • 00888867038875 ()
AR-605-C

  • Device sterilization/disinfection container, reusable
iBALANCE, T20 DRIVER
ARTHREX, INC.
AR-605-8
In Commercial Distribution

  • 00888867038851 ()
AR-605-8

  • Orthopaedic implant driver
iBALANCE TKA, LMR ANT BLADE, 5 DEGREE
ARTHREX, INC.
AR-605-5
In Commercial Distribution

  • 00888867038820 ()
AR-605-5

  • Orthopaedic osteotome blade, reusable
iBALANCE TKA, LMR DISTAL CUT BLOCK
ARTHREX, INC.
AR-605-2
In Commercial Distribution

  • 00888867038790 ()
AR-605-2

  • Suturing unit, single-use
IBALANCE TKA, PATELLA CEMENT CLAMP
ARTHREX, INC.
AR-603-85
In Commercial Distribution

  • 00888867038721 ()
AR-603-85

  • Bone approximation clamp
IBALANCE TKA, UNIVERSAL IMPACTOR HANDLE
ARTHREX, INC.
AR-603-31
In Commercial Distribution

  • 00888867038653 ()
AR-603-31

  • Orthopaedic implant impactor, reusable
iBALANCE PFJ INSTRUMENT CASE
ARTHREX, INC.
AR-602-C
In Commercial Distribution

  • 00888867038578 ()
AR-602-C

  • Endoscope video camera
IBAL PFJ,ANTERI CUT GD BASE,RT
ARTHREX, INC.
AR-602-8R
In Commercial Distribution

  • 00888867038554 ()
AR-602-8R

  • Surgical drill guide, reusable
iBALANCE PFJ, IM DRILL
ARTHREX, INC.
AR-602-6
In Commercial Distribution

  • 00888867038530 ()
AR-602-6

  • Surgical drill guide, reusable
IBAL PFJ,PEGGED FEMTRL,SIZ 3,RT
ARTHREX, INC.
AR-602-56
In Commercial Distribution

  • 00888867038516 ()
AR-602-56

  • Suturing unit, single-use
IBAL PFJ,PEGGED FEM TRL,SIZ 3,LFT
ARTHREX, INC.
AR-602-52
In Commercial Distribution

  • 00888867038479 ()
AR-602-52

  • Suturing unit, single-use
IBAL PFJ,PEGGED FEM TRL,SIZ 1,LFT
ARTHREX, INC.
AR-602-50
In Commercial Distribution

  • 00888867038455 ()
AR-602-50

  • Suturing unit, single-use
IBAL PATLOFEM TRL,SZ 4,RT
ARTHREX, INC.
AR-602-4R
In Commercial Distribution

  • 00888867038431 ()
AR-602-4R

  • Suturing unit, single-use
IBAL PATLOFEM TRL,SZ 4,LFT
ARTHREX, INC.
AR-602-4L
In Commercial Distribution

  • 00888867038424 ()
AR-602-4L

  • Suturing unit, single-use
iBALANCE, PATELLA CALIPERS
ARTHREX, INC.
AR-602-48
In Commercial Distribution

  • 00888867038417 ()
AR-602-48

  • Surgical implant/trial-implant/sizer holder, reusable
iBALANCE PATELLA DRILL GUIDE, 37MM
ARTHREX, INC.
AR-602-47
In Commercial Distribution

  • 00888867038400 ()
AR-602-47

  • Surgical drill guide, reusable
iBALANCE PATELLA DRILL GUIDE, 34MM
ARTHREX, INC.
AR-602-46
In Commercial Distribution

  • 00888867038394 ()
AR-602-46

  • Surgical drill guide, reusable
iBALANCE PATELLA DRILL GUIDE, 30MM
ARTHREX, INC.
AR-602-45
In Commercial Distribution

  • 00888867038387 ()
AR-602-45

  • Surgical drill guide, reusable
iBALANCE PFJ, FEMORAL IMPACTOR HEAD
ARTHREX, INC.
AR-602-43
In Commercial Distribution

  • 00888867038363 ()
AR-602-43

  • Surgical drill guide, reusable
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