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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IBAL TKA,PIN DBL HEDED 1.5" LGTH
ARTHREX, INC.
AR-603-100
In Commercial Distribution

  • 00888867111547 ()
AR-603-100

  • Surgical drill guide, reusable
RPLCMT KEY FOR JACOBS CHUCK FOR AR-600
ARTHREX, INC.
AR-600KEY
In Commercial Distribution

  • 00888867110939 ()
AR-600KEY

  • Surgical drill chuck key
iBALANCE TKA X-RAY TEMPLATES
ARTHREX, INC.
AR-513
In Commercial Distribution

  • 00888867106963 ()
AR-513

  • Suturing unit, single-use
PATELLA FRACTURE INSTR. CASE
ARTHREX, INC.
AR-5050C
In Commercial Distribution

  • 00888867106864 ()
AR-5050C

  • Device sterilization/disinfection container, reusable
XLNG AR-SCOPE STRLIZA CS
ARTHREX, INC.
AR-3130C
In Commercial Distribution

  • 00888867100565 ()
AR-3130C

  • Device sterilization/disinfection container, reusable
SYNERGY LAPAROSCOPE INSTRUMENT CASE, EXT
ARTHREX, INC.
AR-3104C
In Commercial Distribution

  • 00888867100558 ()
AR-3104C

  • Device sterilization/disinfection container, reusable
SYNERGY LAPAROSCOPE INSTRUMENT CASE
ARTHREX, INC.
AR-3103C
In Commercial Distribution

  • 00888867100541 ()
AR-3103C

  • Device sterilization/disinfection container, reusable
PARTIAL ECLIPSE GLENOID IMPACTOR
ARTHREX, INC.
AR-2813
In Commercial Distribution

  • 00888867099005 ()
AR-2813

  • Orthopaedic implant impactor, reusable
PARTIAL ECLIPSE HUMERAL REAMER
ARTHREX, INC.
AR-2810R-35-3
In Commercial Distribution

  • 00888867098978 ()
AR-2810R-35-3

  • Medullary canal orthopaedic reamer, flexible
PARTIAL ECLIPSE HUMERAL REAMER
ARTHREX, INC.
AR-2810R-30-3
In Commercial Distribution

  • 00888867098954 ()
AR-2810R-30-3

  • Medullary canal orthopaedic reamer, flexible
PARTIAL ECLIPSE GLENOID CENTER DRILL
ARTHREX, INC.
AR-2808
In Commercial Distribution

  • 00888867098855 ()
AR-2808

  • Surgical drill guide, reusable
GLENOID IMPLANT RETAINER
ARTHREX, INC.
AR-2806GR
In Commercial Distribution

  • 00888867098848 ()
AR-2806GR

  • Surgical implant/trial-implant/sizer holder, reusable
PT ECLIPSE GLENOID INLAY INSERTR 22MM
ARTHREX, INC.
AR-2806-22
In Commercial Distribution

  • 00888867098831 ()
AR-2806-22

  • Orthopaedic inorganic implant inserter/extractor, reusable
PT ECLIPSE GLENOID INLAY INSERTR 20MM
ARTHREX, INC.
AR-2806-20
In Commercial Distribution

  • 00888867098824 ()
AR-2806-20

  • Orthopaedic inorganic implant inserter/extractor, reusable
PT ECLIPSE GLENOID INLAY INSERTR 18MM
ARTHREX, INC.
AR-2806-18
In Commercial Distribution

  • 00888867098817 ()
AR-2806-18

  • Orthopaedic inorganic implant inserter/extractor, reusable
UNIVERS APEX X -RAY TEMPLATES
ARTHREX, INC.
AR-705
In Commercial Distribution

  • 00888867119338 ()
AR-705

  • Surgical implant template, reusable
UNIVERS REVERS X-RAY TEMPLATES
ARTHREX, INC.
AR-703
In Commercial Distribution

  • 00888867118997 ()
AR-703

  • Surgical implant template, reusable
UNIVERS SHOULDER FRACTURE STEM X-RAY
ARTHREX, INC.
AR-700
In Commercial Distribution

  • 00888867118577 ()
AR-700

  • Surgical implant template, reusable
WISHBONE HIP INSTRUMENT SET
ARTHREX, INC.
AR-6517WS
In Commercial Distribution

  • 00888867118379 ()
AR-6517WS

  • Orthopaedic surgical procedure kit, non-medicated, reusable
HIP ARTHRSCPY MSTR INSTR CS SM INSERT
ARTHREX, INC.
AR-6517C-04
Not in Commercial Distribution

  • 00888867118355 ()
AR-6517C-04

  • Device sterilization/disinfection container, reusable
iBALANCE TKA TRIALS CASE
ARTHREX, INC.
AR-613-C3
In Commercial Distribution

  • 00888867117020 ()
AR-613-C3

  • Device sterilization/disinfection container, reusable
iBALANCE TKA INSTRUMENT CASE
ARTHREX, INC.
AR-613-C1
In Commercial Distribution

  • 00888867117006 ()
AR-613-C1

  • Device sterilization/disinfection container, reusable
iBALANCE TKA, CURVED OSTEOTOME
ARTHREX, INC.
AR-613-66
In Commercial Distribution

  • 00888867116740 ()
AR-613-66

  • Orthopaedic osteotome
IBAL TKA,PATELLA COMBINATION INSTR
ARTHREX, INC.
AR-603-93
In Commercial Distribution

  • 00888867112308 ()
AR-603-93

  • Surgical instrument handle, non-torque-limiting
IBAL TKA,EM ALIGNMNT GD WO SPIKE
ARTHREX, INC.
AR-603-6
In Commercial Distribution

  • 00888867111974 ()
AR-603-6

  • Orthopaedic fixation implant alignment tool
IBALANCE TKA, TIBIAL ALIGNMENT
ARTHREX, INC.
AR-603-46
In Commercial Distribution

  • 00888867111820 ()
AR-603-46

  • Orthopaedic fixation implant alignment tool
IBALANCE TKA, IM TIBIAL ALIGNMENT GUIDE
ARTHREX, INC.
AR-603-10
In Commercial Distribution

  • 00888867111530 ()
AR-603-10

  • Orthopaedic fixation implant alignment tool
IBAL PFJ,POST REFERENCING GD
ARTHREX, INC.
AR-602-7
Not in Commercial Distribution

  • 00888867111417 ()
AR-602-7

  • Surgical drill guide, reusable
UKA TIBIA CUT CORRECTION GUIDE, 2MM
ARTHREX, INC.
AR-601-TCCG-2
In Commercial Distribution

  • 00888867111301 ()
AR-601-TCCG-2

  • Surgical drill guide, reusable
DOUBLE BUNDLE PCL GUIDE SET
ARTHREX, INC.
AR-5015S
In Commercial Distribution

  • 00888867102705 ()
AR-5015S

  • Orthopaedic surgical procedure kit, non-medicated, reusable
DISPOSABLES KIT FOR 2.9MM SHORT PUSHLOCK
ARTHREX, INC.
AR-2923DS
In Commercial Distribution

  • 00888867099210 ()
AR-2923DS

  • Arthroscopic surgical procedure kit, non-medicated, single-use
6 3/4 Inch Miller Rectal Scissors, Double Curved, Blunt, Serrated
Surgical Direct, Inc.
SD90324210
In Commercial Distribution

  • B382SD903242100 ()
SD90324210

  • Rectal speculum
11MM TENDON STRIPPER BLADE
ARTHREX, INC.
AR-2385-11
In Commercial Distribution

  • 10888867098272 ()
  • 00888867098275 ()
AR-2385-11

  • Tendon stripper
10MM TENDON STRIPPER BLADE
ARTHREX, INC.
AR-2385-10
In Commercial Distribution

  • 10888867098265 ()
  • 00888867098268 ()
AR-2385-10

  • Tendon stripper
9MM TENDON STRIPPER BLA
ARTHREX, INC.
AR-2385-09
In Commercial Distribution

  • 10888867098258 ()
  • 00888867098251 ()
AR-2385-09

  • Tendon stripper
QUAD TENDON STRIPPER- CUTTER
ARTHREX, INC.
AR-2384
In Commercial Distribution

  • 00888867098244 ()
AR-2384

  • Tendon stripper
QUAD TENDON GRAFT CUTTING GUIDE
ARTHREX, INC.
AR-2383
In Commercial Distribution

  • 00888867098237 ()
AR-2383

  • Orthopaedic graft guide
MIN INVAS QUAD TENDON HARVEST SYS
ARTHREX, INC.
AR-2382S
In Commercial Distribution

  • 00888867098220 ()
AR-2382S

  • Orthopaedic surgical procedure kit, non-medicated, reusable
MIN INVAS QUAD TENDON HARVEST INST CS
ARTHREX, INC.
AR-2382C
In Commercial Distribution

  • 00888867098213 ()
AR-2382C

  • Device sterilization/disinfection container, reusable
SUTUREPLATE SYSTEM INSTRUMENT SET
ARTHREX, INC.
AR-14003S
In Commercial Distribution

  • 00888867090705 ()
AR-14003S

  • Orthopaedic surgical procedure kit, non-medicated, reusable
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