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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® - 00888867127388

COMPR FT SCRW SYS CADDY,COMMON INST
ARTHREX, INC.
AR-8738C-01
In Commercial Distribution

  • 00888867127388 ()
AR-8738C-01

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867127371

COMPRESSION FT SCREW SYS INSTRUMENT CASE
ARTHREX, INC.
AR-8738C
In Commercial Distribution

  • 00888867127371 ()
AR-8738C

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867127333

QCKFIX CANN SCRW SYS GENERAL INSERT
ARTHREX, INC.
AR-8737C-02
In Commercial Distribution

  • 00888867127333 ()
AR-8737C-02

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867127326

QCKFIX CANN SCRW SYS MICRO/MINI INSERT
ARTHREX, INC.
AR-8737C-01
In Commercial Distribution

  • 00888867127326 ()
AR-8737C-01

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867127296

PARALLEL GUIDE STANDARD CMP FT
ARTHREX, INC.
AR-8737-55
In Commercial Distribution

  • 00888867127296 ()
AR-8737-55

  • Surgical drill guide, reusable

Arthrex® - 00888867127265

PARALLEL GUIDE, MINI CMP FT
ARTHREX, INC.
AR-8737-49
In Commercial Distribution

  • 00888867127265 ()
AR-8737-49

  • Surgical drill guide, reusable

Arthrex® - 00888867127258

PARALLEL GUIDE, MICRO CMP FT
ARTHREX, INC.
AR-8737-48
In Commercial Distribution

  • 00888867127258 ()
AR-8737-48

  • Surgical drill guide, reusable

Arthrex® - 00888867126435

PLAPLE INSTRUMENT SET
ARTHREX, INC.
AR-8714S
In Commercial Distribution

  • 00888867126435 ()
AR-8714S

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Arthrex® - 00888867126152

ANKLE CHONDRAL PICK SET
ARTHREX, INC.
AR-8655SP
In Commercial Distribution

  • 00888867126152 ()
AR-8655SP

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Arthrex® - 00888867126145

ANKLE ARTHROSCOPY INSTRUMENT SET
ARTHREX, INC.
AR-8655S
In Commercial Distribution

  • 00888867126145 ()
AR-8655S

  • Ligament reconstruction instrument set, reusable

Arthrex® - 00888867123588

MODULAR SOFT TISSUE RETRACTOR SET
ARTHREX, INC.
AR-8170S
In Commercial Distribution

  • 00888867123588 ()
AR-8170S

  • Hand-held surgical retractor, reusable

Arthrex® - 00888867123571

MOD SOFT TISS RETRTR,ATRAUMATI
ARTHREX, INC.
AR-8170DS
In Commercial Distribution

  • 00888867123571 ()
AR-8170DS

  • Hand-held surgical retractor, reusable

Arthrex® - 00888867123564

PADDLE SET, ATRAUMATIC 75MM, SOFT TISSUE
ARTHREX, INC.
AR-8170-75DS
In Commercial Distribution

  • 00888867123564 ()
AR-8170-75DS

  • Hand-held surgical retractor, reusable

Arthrex® - 00888867121577

ELBOW UCL RECONSTRUCTION SET
ARTHREX, INC.
AR-7700S
In Commercial Distribution

  • 00888867121577 ()
AR-7700S

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Arthrex® - 00888867121133

TAPERES CRVD NDL 26MM 1/2 CIRCLEX/LOOP
ARTHREX, INC.
AR-7281
In Commercial Distribution

  • 00888867121133 ()
  • 10888867121130 ()
AR-7281

  • Suturing needle, single-use

Arthrex® - 00888867121126

REVSE CUT NDL 36MM 1/2 CIRCLE W/LOOP
ARTHREX, INC.
AR-7280
In Commercial Distribution

  • 00888867121126 ()
  • 10888867121123 ()
AR-7280

  • Suturing needle, single-use

Arthrex® - 00888867118348

HIP ARTHRSCPY MSTR INSTR CS LGR INSERT
ARTHREX, INC.
AR-6517C-03
Not in Commercial Distribution

  • 00888867118348 ()
AR-6517C-03

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867118126

PUMP MOUNT SCRW,1/4"-20 .75" THUMB SCRW
ARTHREX, INC.
AR-6477-01
In Commercial Distribution

  • 00888867118126 ()
AR-6477-01

  • Frame/rail/pole device holder

Arthrex® - 00888867117013

iBALANCE TKA TRIALS CASE
ARTHREX, INC.
AR-613-C2
In Commercial Distribution

  • 00888867117013 ()
AR-613-C2

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867116801

IBALANCE TKA, 2.45" HEADED THREADED PIN
ARTHREX, INC.
AR-613-72
In Commercial Distribution

  • 00888867116801 ()
AR-613-72

  • Surgical drill guide, reusable

Arthrex® - 00888867116788

IBALANCE TKA, 3" HEADLESS THREADED PIN
ARTHREX, INC.
AR-613-7
In Commercial Distribution

  • 00888867116788 ()
AR-613-7

  • Surgical drill guide, reusable

Arthrex® - 00888867116757

iBALANCE TKA, NOTCH CHISEL
ARTHREX, INC.
AR-613-69
In Commercial Distribution

  • 00888867116757 ()
AR-613-69

  • Orthopaedic implant impactor, reusable

Arthrex® - 00888867111868

IBAL TKA,EM ALIGNMNT GD W/SPIKE
ARTHREX, INC.
AR-603-5
In Commercial Distribution

  • 00888867111868 ()
AR-603-5

  • Orthopaedic fixation implant alignment tool

Arthrex® - 00888867111547

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

  • 00888867111547 ()
AR-603-100

  • Surgical drill guide, reusable

Arthrex® - 00888867110939

RPLCMT KEY FOR JACOBS CHUCK FOR AR-600
ARTHREX, INC.
AR-600KEY
In Commercial Distribution

  • 00888867110939 ()
AR-600KEY

  • Surgical drill chuck key

Arthrex® - 00888867106963

iBALANCE TKA X-RAY TEMPLATES
ARTHREX, INC.
AR-513
In Commercial Distribution

  • 00888867106963 ()
AR-513

  • Suturing unit, single-use

Arthrex® - 00888867106864

PATELLA FRACTURE INSTR. CASE
ARTHREX, INC.
AR-5050C
In Commercial Distribution

  • 00888867106864 ()
AR-5050C

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867100565

XLNG AR-SCOPE STRLIZA CS
ARTHREX, INC.
AR-3130C
In Commercial Distribution

  • 00888867100565 ()
AR-3130C

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867100558

SYNERGY LAPAROSCOPE INSTRUMENT CASE, EXT
ARTHREX, INC.
AR-3104C
In Commercial Distribution

  • 00888867100558 ()
AR-3104C

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867100541

SYNERGY LAPAROSCOPE INSTRUMENT CASE
ARTHREX, INC.
AR-3103C
In Commercial Distribution

  • 00888867100541 ()
AR-3103C

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867099005

PARTIAL ECLIPSE GLENOID IMPACTOR
ARTHREX, INC.
AR-2813
In Commercial Distribution

  • 00888867099005 ()
AR-2813

  • Orthopaedic implant impactor, reusable

Arthrex® - 00888867098978

PARTIAL ECLIPSE HUMERAL REAMER
ARTHREX, INC.
AR-2810R-35-3
In Commercial Distribution

  • 00888867098978 ()
AR-2810R-35-3

  • Medullary canal orthopaedic reamer, flexible

Arthrex® - 00888867098954

PARTIAL ECLIPSE HUMERAL REAMER
ARTHREX, INC.
AR-2810R-30-3
In Commercial Distribution

  • 00888867098954 ()
AR-2810R-30-3

  • Medullary canal orthopaedic reamer, flexible

Arthrex® - 00888867098855

PARTIAL ECLIPSE GLENOID CENTER DRILL
ARTHREX, INC.
AR-2808
In Commercial Distribution

  • 00888867098855 ()
AR-2808

  • Surgical drill guide, reusable

Arthrex® - 00888867098848

GLENOID IMPLANT RETAINER
ARTHREX, INC.
AR-2806GR
In Commercial Distribution

  • 00888867098848 ()
AR-2806GR

  • Surgical implant/trial-implant/sizer holder, reusable

Arthrex® - 00888867098831

PT ECLIPSE GLENOID INLAY INSERTR 22MM
ARTHREX, INC.
AR-2806-22
In Commercial Distribution

  • 00888867098831 ()
AR-2806-22

  • Orthopaedic inorganic implant inserter/extractor, reusable

Arthrex® - 00888867098824

PT ECLIPSE GLENOID INLAY INSERTR 20MM
ARTHREX, INC.
AR-2806-20
In Commercial Distribution

  • 00888867098824 ()
AR-2806-20

  • Orthopaedic inorganic implant inserter/extractor, reusable

Arthrex® - 00888867098817

PT ECLIPSE GLENOID INLAY INSERTR 18MM
ARTHREX, INC.
AR-2806-18
In Commercial Distribution

  • 00888867098817 ()
AR-2806-18

  • Orthopaedic inorganic implant inserter/extractor, reusable

Arthrex® - 00888867119338

UNIVERS APEX X -RAY TEMPLATES
ARTHREX, INC.
AR-705
In Commercial Distribution

  • 00888867119338 ()
AR-705

  • Surgical implant template, reusable

Arthrex® - 00888867118997

UNIVERS REVERS X-RAY TEMPLATES
ARTHREX, INC.
AR-703
In Commercial Distribution

  • 00888867118997 ()
AR-703

  • Surgical implant template, reusable

Arthrex® - 00888867118577

UNIVERS SHOULDER FRACTURE STEM X-RAY
ARTHREX, INC.
AR-700
In Commercial Distribution

  • 00888867118577 ()
AR-700

  • Surgical implant template, reusable

Arthrex® - 00888867118379

WISHBONE HIP INSTRUMENT SET
ARTHREX, INC.
AR-6517WS
In Commercial Distribution

  • 00888867118379 ()
AR-6517WS

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Arthrex® - 00888867118355

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

Arthrex® - 00888867117020

iBALANCE TKA TRIALS CASE
ARTHREX, INC.
AR-613-C3
In Commercial Distribution

  • 00888867117020 ()
AR-613-C3

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867117006

iBALANCE TKA INSTRUMENT CASE
ARTHREX, INC.
AR-613-C1
In Commercial Distribution

  • 00888867117006 ()
AR-613-C1

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867116740

iBALANCE TKA, CURVED OSTEOTOME
ARTHREX, INC.
AR-613-66
In Commercial Distribution

  • 00888867116740 ()
AR-613-66

  • Orthopaedic osteotome

Arthrex® - 00888867112308

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

  • 00888867112308 ()
AR-603-93

  • Surgical instrument handle, non-torque-limiting

Arthrex® - 00888867111974

IBAL TKA,EM ALIGNMNT GD WO SPIKE
ARTHREX, INC.
AR-603-6
In Commercial Distribution

  • 00888867111974 ()
AR-603-6

  • Orthopaedic fixation implant alignment tool

Arthrex® - 00888867111820

IBALANCE TKA, TIBIAL ALIGNMENT
ARTHREX, INC.
AR-603-46
In Commercial Distribution

  • 00888867111820 ()
AR-603-46

  • Orthopaedic fixation implant alignment tool

Arthrex® - 00888867111530

IBALANCE TKA, IM TIBIAL ALIGNMENT GUIDE
ARTHREX, INC.
AR-603-10
In Commercial Distribution

  • 00888867111530 ()
AR-603-10

  • Orthopaedic fixation implant alignment tool
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