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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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Arthrex® - 00888867028128

DOVETAIL MEN. ALLOGRAFT ALIGNMENT ROD
ARTHREX, INC.
AR-2961A
In Commercial Distribution

  • 00888867028128 ()
AR-2961A

  • Surgical depth gauge, reusable

Arthrex® - 00888867028074

GRAFT PREP STATION INSTRUMENT CASE
ARTHREX, INC.
AR-2950C
In Commercial Distribution

  • 00888867028074 ()
AR-2950C

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867027961

PARTIAL ECLIPSE IMPLANT DRIVER
ARTHREX, INC.
AR-2855
In Commercial Distribution

  • 00888867027961 ()
AR-2855

  • Orthopaedic inorganic implant inserter/extractor, reusable

Arthrex® - 00888867027862

PARTIAL ECLIPSE DRILL GUIDE/SIZER
ARTHREX, INC.
AR-2820
In Commercial Distribution

  • 00888867027862 ()
AR-2820

  • Surgical drill guide, reusable

Arthrex® - 00888867027046

PERC PINNING,PARALLEL DRL GD
ARTHREX, INC.
AR-2512
In Commercial Distribution

  • 00888867027046 ()
AR-2512

  • Surgical drill guide, reusable

Arthrex® - 00888867039759

SWITCHING STICK, LONG, CANNULATED
ARTHREX, INC.
AR-6520-15
In Commercial Distribution

  • 00888867039759 ()
AR-6520-15

  • Orthopaedic trocar blade, reusable

Arthrex® - 00888867039735

WHISBONE HIP INSTRUMENT CASE
ARTHREX, INC.
AR-6517WC
In Commercial Distribution

  • 00888867039735 ()
AR-6517WC

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867039728

HIP ARTHROSCOPY MASTER INSTRUMENT CASE
ARTHREX, INC.
AR-6517C
In Commercial Distribution

  • 00888867039728 ()
AR-6517C

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867039629

NEEDLE SLEEVE, HIP PORTAL
ARTHREX, INC.
AR-6513-02
In Commercial Distribution

  • 00888867039629 ()
AR-6513-02

  • Surgical drill guide, reusable

Arthrex® - 00888867039612

ACCESS GUIDE, HIP PORTAL
ARTHREX, INC.
AR-6513-01
In Commercial Distribution

  • 00888867039612 ()
AR-6513-01

  • Surgical drill guide, reusable

Arthrex® - 00888867039407

DW CART
ARTHREX, INC.
AR-6481
Not in Commercial Distribution

  • 00888867039407 ()
AR-6481

  • Electromechanical device/system transport trolley

Arthrex® - 00888867038769

iBALANCE TKA, LMR DISTAL CUT GUIDE
ARTHREX, INC.
AR-605-1
In Commercial Distribution

  • 00888867038769 ()
AR-605-1

  • Suturing unit, single-use

Arthrex® - 00888867038653

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

  • 00888867038653 ()
AR-603-31

  • Orthopaedic implant impactor, reusable

Arthrex® - 00888867037908

iBALANCE UKA, RESECTION GUIDE, RIGHT
ARTHREX, INC.
AR-601-TRRM
In Commercial Distribution

  • 00888867037908 ()
AR-601-TRRM

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867037830

iBALANCE UKA, TIBIAL ALIGNMENT GUIDE
ARTHREX, INC.
AR-601-TG00
In Commercial Distribution

  • 00888867037830 ()
AR-601-TG00

  • Suturing unit, single-use

Arthrex® - 00888867037311

IBAL UKA,POST RESECT GD,10MM
ARTHREX, INC.
AR-601-PB10
In Commercial Distribution

  • 00888867037311 ()
AR-601-PB10

  • Suturing unit, single-use

Arthrex® - 00888867037304

IBAL UKA,POST RESECT GD,9MM
ARTHREX, INC.
AR-601-PB09
In Commercial Distribution

  • 00888867037304 ()
AR-601-PB09

  • Suturing unit, single-use

Arthrex® - 00888867037298

IBAL UKA,POST RESECT GD,8MM
ARTHREX, INC.
AR-601-PB08
In Commercial Distribution

  • 00888867037298 ()
AR-601-PB08

  • Suturing unit, single-use

Arthrex® - 00888867037281

IBAL UKA,POST RESCTION GD,7MM
ARTHREX, INC.
AR-601-PB07
In Commercial Distribution

  • 00888867037281 ()
AR-601-PB07

  • Suturing unit, single-use

Arthrex® - 00888867037274

IBAL UKA,POST RESECT GD,6MM
ARTHREX, INC.
AR-601-PB06
In Commercial Distribution

  • 00888867037274 ()
AR-601-PB06

  • Suturing unit, single-use

Arthrex® - 00888867037267

IBAL UKA,POST RESECT GD,5MM
ARTHREX, INC.
AR-601-PB05
In Commercial Distribution

  • 00888867037267 ()
AR-601-PB05

  • Suturing unit, single-use

Arthrex® - 00888867037250

IBAL UKA,POST RESECT GD,4MM
ARTHREX, INC.
AR-601-PB04
In Commercial Distribution

  • 00888867037250 ()
AR-601-PB04

  • Suturing unit, single-use

Arthrex® - 00888867037243

IBAL UKA,POST RESECT GD,3MM
ARTHREX, INC.
AR-601-PB03
In Commercial Distribution

  • 00888867037243 ()
AR-601-PB03

  • Suturing unit, single-use

Arthrex® - 00888867036994

IBAL UKA,CHAMFER & PEG GD,SZ 6,RM/LL
ARTHREX, INC.
AR-601-CRMF
In Commercial Distribution

  • 00888867036994 ()
AR-601-CRMF

  • Arthroscopic shaver system blade, reusable

Arthrex® - 00888867036987

IBAL UKA,CHAMFER & PEG GD,SZ 5,RM/LL
ARTHREX, INC.
AR-601-CRME
In Commercial Distribution

  • 00888867036987 ()
AR-601-CRME

  • Bone lever/elevator, reusable

Arthrex® - 00888867036963

IBAL UKA,CHAMFER & PEG GD,SZ 3,RM/LL
ARTHREX, INC.
AR-601-CRMC
In Commercial Distribution

  • 00888867036963 ()
AR-601-CRMC

  • Orthopaedic fixation implant alignment tool

Arthrex® - 00888867036918

IBAL UKA,CHAMFER & PEG GD,SZ 5,LM/RL
ARTHREX, INC.
AR-601-CLME
In Commercial Distribution

  • 00888867036918 ()
AR-601-CLME

  • Orthopaedic fixation implant alignment tool

Arthrex® - 00888867036895

IBAL UKA,CHAMFER & PEG GD,SZ 3,LM/RL
ARTHREX, INC.
AR-601-CLMC
In Commercial Distribution

  • 00888867036895 ()
AR-601-CLMC

  • Orthopaedic fixation implant alignment tool

Arthrex® - 00888867036871

IBAL UKA,CHAMFER & PEG GD,SZ 1,LM/RL
ARTHREX, INC.
AR-601-CLMA
In Commercial Distribution

  • 00888867036871 ()
AR-601-CLMA

  • Orthopaedic fixation implant alignment tool

Arthrex® - 00888867036864

IBALANCE UKA INSTRUMENT CASE
ARTHREX, INC.
AR-601-C2
In Commercial Distribution

  • 00888867036864 ()
AR-601-C2

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867036840

IBALANCE UKA, BONE CALIPER
ARTHREX, INC.
AR-601-BC00
In Commercial Distribution

  • 00888867036840 ()
AR-601-BC00

  • Suturing unit, single-use

Arthrex® - 00888867036802

600 PWR 2 HAND PIECE&BATTERY HOUSING CS
ARTHREX, INC.
AR-600C-3
In Commercial Distribution

  • 00888867036802 ()
AR-600C-3

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867036796

600 PWR SYS INTRUMENT CS W/2 HAND PIECES
ARTHREX, INC.
AR-600C-2
In Commercial Distribution

  • 00888867036796 ()
AR-600C-2

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867035980

CHONDROGUARD DRILL GUIDE HIP, 4MM OFFSET
ARTHREX, INC.
AR-5600-01
In Commercial Distribution

  • 00888867035980 ()
AR-5600-01

  • Surgical drill guide, reusable

Arthrex® - 00888867035911

Collateral Ligament Recon. Inst. Case
ARTHREX, INC.
AR-5500C
In Commercial Distribution

  • 00888867035911 ()
AR-5500C

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867035836

INSERTER, 8/9 MM, GRAFTBOLT
ARTHREX, INC.
AR-5104
In Commercial Distribution

  • 00888867035836 ()
AR-5104

  • Orthopaedic inorganic implant inserter/extractor, reusable

Arthrex® - 00888867035829

INSERTER, 7MM,GRAFTBOLT
ARTHREX, INC.
AR-5103
In Commercial Distribution

  • 00888867035829 ()
AR-5103

  • Orthopaedic inorganic implant inserter/extractor, reusable

Arthrex® - 00888867035805

INSERTER, 10MM, GRAFTBOLT
ARTHREX, INC.
AR-5101
In Commercial Distribution

  • 00888867035805 ()
AR-5101

  • Orthopaedic inorganic implant inserter/extractor, reusable

Arthrex® - 00888867035782

GRAFTBOLT INSTRUMENT CASE
ARTHREX, INC.
AR-5100C
In Commercial Distribution

  • 00888867035782 ()
AR-5100C

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867035690

SUTRLASSO TM SD SUTR PASS SYS CS
ARTHREX, INC.
AR-5068RC
In Commercial Distribution

  • 00888867035690 ()
AR-5068RC

  • Orthopaedic trocar blade, reusable
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