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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ELEVATOR FOR STAPLES REMOVAL
ARTHREX, INC.
AR-1005E
In Commercial Distribution

  • 00888867002425 ()
AR-1005E

  • Bone lever/elevator, reusable
SUTURE PASSER, TRANSOSSEOUS
ARTHREX, INC.
AR-1000
In Commercial Distribution

  • 00888867002340 ()
AR-1000

  • Suturing unit, single-use
ANKLE CLAMP
ARTHREX, INC.
AR-005-AC00
In Commercial Distribution

  • 00888867002326 ()
AR-005-AC00

  • Bone approximation clamp
INSTRUMENT CASE REPLACEMENT MAT
ARTHREX, INC.
AR-0016
In Commercial Distribution

  • 00888867002302 ()
AR-0016

  • Device sterilization/disinfection container, reusable
TUOHY DELIVERY NEEDLE, 17 GAUGE X 6"
ARTHREX, INC.
ABS-21000
In Commercial Distribution

  • 10888867002002 ()
  • 00888867002005 ()
ABS-21000

  • Suturing needle, single-use
FENESTRATED DELIVERY NEEDLE
ARTHREX, INC.
ABS-20000
In Commercial Distribution

  • 10888867001999 ()
  • 00888867001992 ()
ABS-20000

  • Body aspiration needle, single-use
FUNNEL
ARTHREX, INC.
ABS-1003
In Commercial Distribution

  • 00888867001954 ()
ABS-1003

  • Bone graft delivery kit
TRANSFIX II ACL, RECONSTRUCTION CASE
ARTHREX, INC.
AR-1817TC
In Commercial Distribution

  • 00888867021549 ()
AR-1817TC

  • Device sterilization/disinfection container, reusable
UNIVERSAL INSTRUMENTATION CASE
ARTHREX, INC.
AR-1817C
In Commercial Distribution

  • 00888867021532 ()
AR-1817C

  • Device sterilization/disinfection container, reusable
TRANSTIBIAL ACL RECONSTRUCTION CASE
ARTHREX, INC.
AR-1817AC
In Commercial Distribution

  • 00888867021525 ()
AR-1817AC

  • Device sterilization/disinfection container, reusable
GRAFT HARVESTING CUTTING GUIDE, 10.5MM
ARTHREX, INC.
AR-1811
In Commercial Distribution

  • 00888867021495 ()
AR-1811

  • Surgical depth gauge, reusable
GRAFT HARVESTING CUTTING GUIDE, 9.5MM
ARTHREX, INC.
AR-1810
In Commercial Distribution

  • 00888867021471 ()
AR-1810

  • Surgical depth gauge, reusable
GRAFT HARVESTING CUTTING GUIDE, 8.5MM
ARTHREX, INC.
AR-1809
In Commercial Distribution

  • 00888867021457 ()
AR-1809

  • Surgical depth gauge, reusable
FIBERWIRE GRASPER 220MM W/SR HANDLE
ARTHREX, INC.
AR-16975SR
In Commercial Distribution

  • 00888867020979 ()
AR-16975SR

  • Suturing unit, reusable
KINGFISHER 220MM W/SR HANDLE
ARTHREX, INC.
AR-16970SR
In Commercial Distribution

  • 00888867020955 ()
AR-16970SR

  • Suturing unit, reusable
SUTR CUTR,4.2MMX 220MM O/E LN W/WB HNDL
ARTHREX, INC.
AR-16794LW
In Commercial Distribution

  • 00888867020900 ()
AR-16794LW

  • General-purpose surgical scissors, reusable
SUTURE CUTTER, 4.2MM, STR SHAFT 220MM
ARTHREX, INC.
AR-16250
In Commercial Distribution

  • 00888867020177 ()
AR-16250

  • Suture cutter, reusable
DETERMINATOR GRAFT LENGTH GUIDE
ARTHREX, INC.
AR-1591
In Commercial Distribution

  • 00888867019867 ()
AR-1591

  • Ligament graft sizer, invasive
TIGHTROPE SUTURE TENSIONER
ARTHREX, INC.
AR-1588H
In Commercial Distribution

  • 00888867019546 ()
AR-1588H

  • Suturing unit, reusable
HANDLE FOR SAW TEMPLATE
ARTHREX, INC.
AR-14520H
In Commercial Distribution

  • 00888867017764 ()
AR-14520H

  • Surgical drill guide, reusable
RETRACTOR, GRAFT HARVESTING
ARTHREX, INC.
AR-1420
In Commercial Distribution

  • 00888867017283 ()
AR-1420

  • Hand-held surgical retractor, reusable
IMPACTOR, BONE GRAFT
ARTHREX, INC.
AR-1417
In Commercial Distribution

  • 00888867017269 ()
AR-1417

  • Orthopaedic implant impactor, reusable
2.5MM DRILL GUIDE
ARTHREX, INC.
AR-14029
In Commercial Distribution

  • 00888867016507 ()
AR-14029

  • Surgical drill guide, reusable
DEPTH GUIDE, PROXIMAL SCREWS
ARTHREX, INC.
AR-14013
In Commercial Distribution

  • 00888867016262 ()
AR-14013

  • Surgical depth gauge, reusable
BONE CUTTING FORCEPS
ARTHREX, INC.
AR-1367F
In Commercial Distribution

  • 00888867014572 ()
AR-1367F

  • Orthopaedic implantable-device cutter
ACL PCL CORTICAL FIX. CASE
ARTHREX, INC.
AR-1359C
In Commercial Distribution

  • 00888867013957 ()
AR-1359C

  • Device sterilization/disinfection container, reusable
TISS ELEVTR,15°DOWN-30°RT
ARTHREX, INC.
AR-1344-1530R
In Commercial Distribution

  • 00888867013209 ()
AR-1344-1530R

  • Bone lever/elevator, reusable
TISSUE ELEVATOR, 30 DEGREES
ARTHREX, INC.
AR-1342H-30
In Commercial Distribution

  • 00888867012882 ()
AR-1342H-30

  • Bone lever/elevator, reusable
TISSUE ELEVATOR, 15 DEGREES
ARTHREX, INC.
AR-1342H-15
In Commercial Distribution

  • 00888867012875 ()
AR-1342H-15

  • Bone lever/elevator, reusable
CUTTING GUIDE, RIGHT LG/XL
ARTHREX, INC.
AR-13428-02
In Commercial Distribution

  • 00888867012820 ()
AR-13428-02

  • Osteotomy guide, reusable
CUTTING GUIDE, LEFT LG/XL
ARTHREX, INC.
AR-13428-01
In Commercial Distribution

  • 00888867012813 ()
AR-13428-01

  • Osteotomy guide, reusable
CUTTING GUIDE, RIGHT SM/MD
ARTHREX, INC.
AR-13427-02
In Commercial Distribution

  • 00888867012806 ()
AR-13427-02

  • Osteotomy guide, reusable
CUTTING GUIDE, LEFT SM/MD
ARTHREX, INC.
AR-13427-01
In Commercial Distribution

  • 00888867012790 ()
AR-13427-01

  • Osteotomy guide, reusable
ELEVATOR, 30 DEGREE SHOULDER TISSUE
ARTHREX, INC.
AR-1342-30
In Commercial Distribution

  • 00888867012684 ()
AR-1342-30

  • Bone lever/elevator, reusable
ACL/PCL GRAFT PASS FORCEPS W/SR HNDL
ARTHREX, INC.
AR-13400SR
In Commercial Distribution

  • 00888867011953 ()
AR-13400SR

  • Suturing unit, reusable
MEDIAL PORTAL TRANSFIX TUNNEL HOOK, 8MM
ARTHREX, INC.
AR-1977-08MP
In Commercial Distribution

  • 00888867024861 ()
AR-1977-08MP

  • Soft-tissue surgical hook, reusable
MEDIAL PORTAL TRANSFIX TUNNEL HOOK, 7MM
ARTHREX, INC.
AR-1977-07MP
In Commercial Distribution

  • 00888867024830 ()
AR-1977-07MP

  • Soft-tissue surgical hook, reusable
GUIDE SLEEVE, 3MM TRANSFIX II
ARTHREX, INC.
AR-1976
In Commercial Distribution

  • 00888867024748 ()
AR-1976

  • Surgical drill guide, reusable
DRILL GUIDE ASSEMBLY FOR TRANSFIX II
ARTHREX, INC.
AR-1975
In Commercial Distribution

  • 00888867024700 ()
AR-1975

  • Surgical drill guide, reusable
DRIVER, BIOCOMPOSITE TRANSFIX
ARTHREX, INC.
AR-1973CD
In Commercial Distribution

  • 00888867024649 ()
AR-1973CD

  • Orthopaedic inorganic implant inserter/extractor, reusable
DRL GD,3.0 MM HIP,SADDLE,CANN TRCR
ARTHREX, INC.
AR-1949H-3.0
In Commercial Distribution

  • 00888867024342 ()
AR-1949H-3.0

  • Surgical drill guide, reusable
DRL GD,2.4MM HIP,SADDLE,CANN TRCR
ARTHREX, INC.
AR-1949H-2.4
In Commercial Distribution

  • 00888867024335 ()
AR-1949H-2.4

  • Surgical drill guide, reusable
OFFSET GUIDE, FOR 2.4MM SUTURETAK
ARTHREX, INC.
AR-1948R
In Commercial Distribution

  • 00888867024298 ()
AR-1948R

  • Surgical drill guide, reusable
OFFSET GUIDE REUSABLE
ARTHREX, INC.
AR-1934R
In Commercial Distribution

  • 00888867024205 ()
AR-1934R

  • Surgical drill guide, reusable
METAL OFFSET GUIDE, DISPOSABLE
ARTHREX, INC.
AR-1934GS
In Commercial Distribution

  • 10888867024097 ()
  • 00888867024090 ()
AR-1934GS

  • Surgical drill guide, single-use
3MM SUTURETAK INSTRUMENTATION CASE
ARTHREX, INC.
AR-1934C
In Commercial Distribution

  • 00888867024014 ()
AR-1934C

  • Device sterilization/disinfection container, reusable
CORKSCREW FT COMBO PUNCH/TAP, 4.5MM
ARTHREX, INC.
AR-1927PTB-45
In Commercial Distribution

  • 00888867023680 ()
AR-1927PTB-45

  • Orthopaedic implant impactor, reusable
DISPOSABLE KIT FOR 2.9MM PUSHLOCK
ARTHREX, INC.
AR-1923DS
In Commercial Distribution

  • 00888867023079 ()
AR-1923DS

  • Arthroscopic surgical procedure kit, non-medicated, single-use
DISPOSABLE KIT FOR 2.9MM HIP PUSHLOCK
ARTHREX, INC.
AR-1923DHS
In Commercial Distribution

  • 00888867023062 ()
AR-1923DHS

  • Arthroscopic surgical procedure kit, non-medicated, single-use
DOVETAIL MENISCL ALOGRAFT CS TRAY INSERT
ARTHREX, INC.
AR-1970C-1
In Commercial Distribution

  • 00888867024618 ()
AR-1970C-1

  • Device sterilization/disinfection container, reusable
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