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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® - 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

Arthrex® - 00888867111417

IBAL PFJ,POST REFERENCING GD
ARTHREX, INC.
AR-602-7
Not in Commercial Distribution

  • 00888867111417 ()
AR-602-7

  • Surgical drill guide, reusable

Arthrex® - 00888867111301

UKA TIBIA CUT CORRECTION GUIDE, 2MM
ARTHREX, INC.
AR-601-TCCG-2
In Commercial Distribution

  • 00888867111301 ()
AR-601-TCCG-2

  • Surgical drill guide, reusable

Arthrex® - 00888867102705

DOUBLE BUNDLE PCL GUIDE SET
ARTHREX, INC.
AR-5015S
In Commercial Distribution

  • 00888867102705 ()
AR-5015S

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Arthrex® - 00888867099210

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

Surgical Direct - B382SD903242100

6 3/4 Inch Miller Rectal Scissors, Double Curved, Blunt, Serrated
Surgical Direct, Inc.
SD90324210
In Commercial Distribution

  • B382SD903242100 ()
SD90324210

  • Rectal speculum

Arthrex® - 00888867098275

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

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

  • Tendon stripper

Arthrex® - 00888867098268

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

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

  • Tendon stripper

Arthrex® - 00888867098251

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

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

  • Tendon stripper

Arthrex® - 00888867098244

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

  • 00888867098244 ()
AR-2384

  • Tendon stripper

Arthrex® - 00888867098237

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

  • 00888867098237 ()
AR-2383

  • Orthopaedic graft guide

Arthrex® - 00888867098220

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

  • 00888867098220 ()
AR-2382S

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Arthrex® - 00888867098213

MIN INVAS QUAD TENDON HARVEST INST CS
ARTHREX, INC.
AR-2382C
In Commercial Distribution

  • 00888867098213 ()
AR-2382C

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867090705

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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