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 PFJ BLADE KIT, SIZE 3
ARTHREX, INC.
AR-602-28
In Commercial Distribution

  • 00888867038257 ()
AR-602-28

  • Suturing unit, single-use
iBALANCE PFJ BLADE KIT, SIZE 2
ARTHREX, INC.
AR-602-27
In Commercial Distribution

  • 00888867038240 ()
AR-602-27

  • Suturing unit, single-use
iBALANCE PFJ BLADE KIT, SIZE 1
ARTHREX, INC.
AR-602-26
In Commercial Distribution

  • 00888867038233 ()
AR-602-26

  • Suturing unit, single-use
iBALANCE PFJ, BLADE HANDLE
ARTHREX, INC.
AR-602-25
In Commercial Distribution

  • 00888867038226 ()
AR-602-25

  • Surgical drill guide, reusable
iBALANCE PFJ, BLADE STABILIZER HANDLER
ARTHREX, INC.
AR-602-24
In Commercial Distribution

  • 00888867038219 ()
AR-602-24

  • Surgical drill guide, reusable
iBALANCE PFJ, BLADE STABILIZER SIZE 4
ARTHREX, INC.
AR-602-23
In Commercial Distribution

  • 00888867038202 ()
AR-602-23

  • Surgical drill guide, reusable
iBALANCE PFJ, BLADE STABILIZER SIZE 3
ARTHREX, INC.
AR-602-22
In Commercial Distribution

  • 00888867038196 ()
AR-602-22

  • Surgical drill guide, reusable
iBALANCE PFJ, BLADE STABILIZER SIZE 2
ARTHREX, INC.
AR-602-21
In Commercial Distribution

  • 00888867038189 ()
AR-602-21

  • Surgical drill guide, reusable
iBALANCE PFJ, BLADE STABILIZER SIZE 1
ARTHREX, INC.
AR-602-20
In Commercial Distribution

  • 00888867038172 ()
AR-602-20

  • Surgical drill guide, reusable
IBAL PATLOFEM TRL,SZ 1,RT
ARTHREX, INC.
AR-602-1R
In Commercial Distribution

  • 00888867038165 ()
AR-602-1R

  • Suturing unit, single-use
IBAL PATLOFEM TRL,SZ 1,LFT
ARTHREX, INC.
AR-602-1L
In Commercial Distribution

  • 00888867038158 ()
AR-602-1L

  • Suturing unit, single-use
iBALANCE PFJ, TROCHLEAR REAMER SIZE 4
ARTHREX, INC.
AR-602-19
In Commercial Distribution

  • 00888867038141 ()
AR-602-19

  • Bone-resection orthopaedic reamer, reusable
iBALANCE PFJ, TROCHLEAR REAMER SIZE 3
ARTHREX, INC.
AR-602-18
In Commercial Distribution

  • 00888867038134 ()
AR-602-18

  • Bone-resection orthopaedic reamer, reusable
iBALANCE PFJ, TROCHLEAR REAMER SIZE 2
ARTHREX, INC.
AR-602-17
In Commercial Distribution

  • 00888867038127 ()
AR-602-17

  • Bone-resection orthopaedic reamer, reusable
iBALANCE PFJ, TROCHLEAR REAMER SIZE 1
ARTHREX, INC.
AR-602-16
In Commercial Distribution

  • 00888867038110 ()
AR-602-16

  • Bone-resection orthopaedic reamer, reusable
iBALANCE PFJ, DISTAL/ PROXIMAL STYLUS
ARTHREX, INC.
AR-602-15
In Commercial Distribution

  • 00888867038103 ()
AR-602-15

  • Surgical drill guide, reusable
IBALANCE PFJ, FINISHING GUIDE, SIZE 4
ARTHREX, INC.
AR-602-14
In Commercial Distribution

  • 00888867038097 ()
AR-602-14

  • Surgical drill guide, reusable
IBALANCE PFJ, FINISHING GUIDE, SIZE 3
ARTHREX, INC.
AR-602-13
In Commercial Distribution

  • 00888867038080 ()
AR-602-13

  • Surgical drill guide, reusable
IBALANCE PFJ, FINISHING GUIDE, SIZE 2
ARTHREX, INC.
AR-602-12
In Commercial Distribution

  • 00888867038073 ()
AR-602-12

  • Surgical drill guide, reusable
IBALANCE PFJ, FINISHING GUIDE, SIZE 1
ARTHREX, INC.
AR-602-11
In Commercial Distribution

  • 00888867038066 ()
AR-602-11

  • Surgical drill guide, reusable
iBALANCE PFJ, ANTERIOR CUT STYLUS
ARTHREX, INC.
AR-602-10
In Commercial Distribution

  • 00888867038059 ()
AR-602-10

  • Arm procedure positioner, reusable
IBAL UKA,TIB SIZING GD,SZ 6,RM
ARTHREX, INC.
AR-601-TTR6
In Commercial Distribution

  • 00888867038042 ()
AR-601-TTR6

  • Suturing unit, single-use
IBAL UKA,TIB SIZING GD,SZ 5,RM
ARTHREX, INC.
AR-601-TTR5
In Commercial Distribution

  • 00888867038035 ()
AR-601-TTR5

  • Suturing unit, single-use
IBAL UKA,TIB SIZING GD,SZ 4,RM
ARTHREX, INC.
AR-601-TTR4
In Commercial Distribution

  • 00888867038028 ()
AR-601-TTR4

  • Suturing unit, single-use
IBAL UKA,TIB SIZING GD,SZ 3,RM
ARTHREX, INC.
AR-601-TTR3
In Commercial Distribution

  • 00888867038011 ()
AR-601-TTR3

  • Suturing unit, single-use
IBAL UKA,TIB SIZING GD,SZ 2,RM
ARTHREX, INC.
AR-601-TTR2
In Commercial Distribution

  • 00888867038004 ()
AR-601-TTR2

  • Suturing unit, single-use
IBAL UKA,TIB SIZING GD,SZ 1,RM
ARTHREX, INC.
AR-601-TTR1
In Commercial Distribution

  • 00888867037991 ()
AR-601-TTR1

  • Suturing unit, single-use
IBAL UKA,TIB SIZING GD,SZ 6,LM
ARTHREX, INC.
AR-601-TTL6
In Commercial Distribution

  • 00888867037984 ()
AR-601-TTL6

  • Suturing unit, single-use
IBAL UKA,TIB SIZING GD,SZ 5,LM
ARTHREX, INC.
AR-601-TTL5
In Commercial Distribution

  • 00888867037977 ()
AR-601-TTL5

  • Suturing unit, single-use
IBAL UKA,TIB SIZING GD,SZ 4,LM
ARTHREX, INC.
AR-601-TTL4
In Commercial Distribution

  • 00888867037960 ()
AR-601-TTL4

  • Suturing unit, single-use
IBAL UKA,TIB SIZING GD,SZ 3,LM
ARTHREX, INC.
AR-601-TTL3
In Commercial Distribution

  • 00888867037953 ()
AR-601-TTL3

  • Suturing unit, single-use
IBAL UKA,TIB SIZING GD,SZ 2,LM
ARTHREX, INC.
AR-601-TTL2
In Commercial Distribution

  • 00888867037946 ()
AR-601-TTL2

  • 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, TIBIAL STYLUS, 5MM
ARTHREX, INC.
AR-601-TS05
In Commercial Distribution

  • 00888867037922 ()
AR-601-TS05

  • Suturing unit, single-use
iBALANCE UKA, TIBIAL STYLUS, 0MM
ARTHREX, INC.
AR-601-TS00
In Commercial Distribution

  • 00888867037915 ()
AR-601-TS00

  • 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
UNI-KNEE TIBIA PEG DRILL DIA. .312
ARTHREX, INC.
AR-601-TPD0
In Commercial Distribution

  • 00888867037885 ()
AR-601-TPD0

  • Suturing unit, single-use
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
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