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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iBALANCE TKA, LMR TIB CUT BLOCK
ARTHREX, INC.
AR-605-6
In Commercial Distribution

  • 00888867038837 ()
AR-605-6

  • Orthopaedic prosthesis implantation positioning instrument, reusable
iBALANCE PFJ, ANTERIOR CUT GUIDE
ARTHREX, INC.
AR-602-9
In Commercial Distribution

  • 00888867038561 ()
AR-602-9

  • Surgical drill guide, reusable
IBAL PFJ,ANTERI CUT GD BASE,LFT
ARTHREX, INC.
AR-602-8L
In Commercial Distribution

  • 00888867038547 ()
AR-602-8L

  • 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 4,RT
ARTHREX, INC.
AR-602-57
In Commercial Distribution

  • 00888867038523 ()
AR-602-57

  • Suturing unit, single-use
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 FEMTRL,SIZ 2,RT
ARTHREX, INC.
AR-602-55
In Commercial Distribution

  • 00888867038509 ()
AR-602-55

  • Suturing unit, single-use
IBAL PFJ,PEGGED FEMTRL,SIZ 1,RT
ARTHREX, INC.
AR-602-54
In Commercial Distribution

  • 00888867038493 ()
AR-602-54

  • Suturing unit, single-use
IBAL PFJ,PEGGED FEM TRL,SIZ 4,LFT
ARTHREX, INC.
AR-602-53
In Commercial Distribution

  • 00888867038486 ()
AR-602-53

  • 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 2,LFT
ARTHREX, INC.
AR-602-51
In Commercial Distribution

  • 00888867038462 ()
AR-602-51

  • 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 PFJ,ANTERI CORTEX ALIGNMNT GD
ARTHREX, INC.
AR-602-5
In Commercial Distribution

  • 00888867038448 ()
AR-602-5

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

  • 00888867038387 ()
AR-602-45

  • Surgical drill guide, reusable
IBAL PFJ,PEG DRL STABILIZER SZ 4
ARTHREX, INC.
AR-602-41
In Commercial Distribution

  • 00888867038349 ()
AR-602-41

  • Surgical drill guide, reusable
IBAL PATLOFEM TRL,SZ 3,RT
ARTHREX, INC.
AR-602-3R
In Commercial Distribution

  • 00888867038325 ()
AR-602-3R

  • Suturing unit, single-use
IBAL UKA,TIB SIZING GD,SZ 1,LM
ARTHREX, INC.
AR-601-TTL1
In Commercial Distribution

  • 00888867037939 ()
AR-601-TTL1

  • Suturing unit, single-use
iBALANCE UKA, RESECTION GUIDE, RIGHT
ARTHREX, INC.
AR-601-TRRM
In Commercial Distribution

  • 00888867037908 ()
AR-601-TRRM

  • Device sterilization/disinfection container, reusable
iBALANCE UKA, RESECTION GUIDE, LEFT
ARTHREX, INC.
AR-601-TRLM
In Commercial Distribution

  • 00888867037892 ()
AR-601-TRLM

  • Device sterilization/disinfection container, reusable
iBALANCE UKA, TIBIAL KEEL PUNCH
ARTHREX, INC.
AR-601-TKBR
In Commercial Distribution

  • 00888867037861 ()
AR-601-TKBR

  • Device sterilization/disinfection container, reusable
iBALANCE UKA TIBIAL IMP- ACTOR HEAD
ARTHREX, INC.
AR-601-TIH0
In Commercial Distribution

  • 00888867037854 ()
AR-601-TIH0

  • Orthopaedic surgical distractor, internal
iBALANCE UKA TIBIAL IMP- ACTOR BODY ASSY
ARTHREX, INC.
AR-601-TIB0
In Commercial Distribution

  • 00888867037847 ()
AR-601-TIB0

  • Orthopaedic surgical distractor, internal
iBALANCE UKA, TIBIAL ALIGNMENT GUIDE
ARTHREX, INC.
AR-601-TG00
In Commercial Distribution

  • 00888867037830 ()
AR-601-TG00

  • Suturing unit, single-use
iBALANCE UKA, BASE PLATE TRIAL, SIZE 6
ARTHREX, INC.
AR-601-TBP6
In Commercial Distribution

  • 00888867037823 ()
AR-601-TBP6

  • Surgical implant/trial-implant/sizer holder, reusable
iBALANCE UKA, BASE PLATE TRIAL, SIZE 5
ARTHREX, INC.
AR-601-TBP5
In Commercial Distribution

  • 00888867037816 ()
AR-601-TBP5

  • Surgical implant/trial-implant/sizer holder, reusable
iBALANCE UKA, BASE PLATE TRIAL, SIZE 4
ARTHREX, INC.
AR-601-TBP4
In Commercial Distribution

  • 00888867037809 ()
AR-601-TBP4

  • Surgical implant/trial-implant/sizer holder, reusable
iBALANCE UKA, BASE PLATE TRIAL, SIZE 3
ARTHREX, INC.
AR-601-TBP3
In Commercial Distribution

  • 00888867037793 ()
AR-601-TBP3

  • Surgical implant/trial-implant/sizer holder, reusable
iBALANCE UKA, BASE PLATE TRIAL, SIZE 2
ARTHREX, INC.
AR-601-TBP2
In Commercial Distribution

  • 00888867037786 ()
AR-601-TBP2

  • Surgical implant/trial-implant/sizer holder, reusable
iBALANCE UKA, BASE PLATE TRIAL, SIZE 1
ARTHREX, INC.
AR-601-TBP1
In Commercial Distribution

  • 00888867037779 ()
AR-601-TBP1

  • Surgical implant/trial-implant/sizer holder, reusable
iBALANCE UKA TIBIAL BEA- RING PULLER
ARTHREX, INC.
AR-601-TBP0
In Commercial Distribution

  • 00888867037762 ()
AR-601-TBP0

  • Electromechanical device/system transport trolley
IBAL UKA TIB BEA-RING TRL SZ 6 || 9MM
ARTHREX, INC.
AR-601-TBF9
In Commercial Distribution

  • 00888867037755 ()
AR-601-TBF9

  • Knee tibia prosthesis trial, reusable
IBAL UKA TIB BEA-RING TRL SZ 6 || 12MM
ARTHREX, INC.
AR-601-TBF2
In Commercial Distribution

  • 00888867037724 ()
AR-601-TBF2

  • Knee tibia prosthesis trial, reusable
IBAL UKA TIB BEA-RING TRL SZ 6 || 11MM
ARTHREX, INC.
AR-601-TBF1
In Commercial Distribution

  • 00888867037717 ()
AR-601-TBF1

  • Knee tibia prosthesis trial, reusable
IBAL UKA TIB BEA-RING TRL SZ 6 || 10MM
ARTHREX, INC.
AR-601-TBF0
In Commercial Distribution

  • 00888867037700 ()
AR-601-TBF0

  • Knee tibia prosthesis trial, reusable
IBAL UKA TIB BEA-RING TRL SZ 5 || 9MM
ARTHREX, INC.
AR-601-TBE9
In Commercial Distribution

  • 00888867037694 ()
AR-601-TBE9

  • Knee tibia prosthesis trial, reusable
IBAL UKA TIB BEA-RING TRL SZ 5 || 8MM
ARTHREX, INC.
AR-601-TBE8
In Commercial Distribution

  • 00888867037687 ()
AR-601-TBE8

  • Knee tibia prosthesis trial, reusable
IBAL UKA TIB BEA-RING TRL SZ 5 || 14MM
ARTHREX, INC.
AR-601-TBE4
In Commercial Distribution

  • 00888867037670 ()
AR-601-TBE4

  • Knee tibia prosthesis trial, reusable
IBAL UKA TIB BEA-RING TRL SZ 5 || 12MM
ARTHREX, INC.
AR-601-TBE2
In Commercial Distribution

  • 00888867037663 ()
AR-601-TBE2

  • Knee tibia prosthesis trial, reusable
IBAL UKA TIB BEA-RING TRL SZ 5 || 11MM
ARTHREX, INC.
AR-601-TBE1
In Commercial Distribution

  • 00888867037656 ()
AR-601-TBE1

  • Knee tibia prosthesis trial, reusable
IBAL UKA TIB BEA-RING TRL SZ 5 || 10MM
ARTHREX, INC.
AR-601-TBE0
In Commercial Distribution

  • 00888867037649 ()
AR-601-TBE0

  • Knee tibia prosthesis trial, reusable
IBAL UKA TIB BEA-RING TRL SZ 4 || 8MM
ARTHREX, INC.
AR-601-TBD8
In Commercial Distribution

  • 00888867037625 ()
AR-601-TBD8

  • Knee tibia prosthesis trial, reusable
IBAL UKA TIB BEA-RING TRL SZ 4 || 14MM
ARTHREX, INC.
AR-601-TBD4
In Commercial Distribution

  • 00888867037618 ()
AR-601-TBD4

  • Knee tibia prosthesis trial, reusable
IBAL UKA TIB BEA-RING TRL SZ 4 || 12MM
ARTHREX, INC.
AR-601-TBD2
In Commercial Distribution

  • 00888867037601 ()
AR-601-TBD2

  • Knee tibia prosthesis trial, reusable
IBAL UKA TIB BEA-RING TRL SZ 4 || 11MM
ARTHREX, INC.
AR-601-TBD1
In Commercial Distribution

  • 00888867037595 ()
AR-601-TBD1

  • Knee tibia prosthesis trial, reusable
IBAL UKA TIB BEA-RING TRL SZ 4 || 10MM
ARTHREX, INC.
AR-601-TBD0
In Commercial Distribution

  • 00888867037588 ()
AR-601-TBD0

  • Knee tibia prosthesis trial, reusable
IBAL UKA TIB BEA-RING TRL SZ 3 || 9MM
ARTHREX, INC.
AR-601-TBC9
In Commercial Distribution

  • 00888867037571 ()
AR-601-TBC9

  • Knee tibia prosthesis trial, reusable
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