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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® - 00888867135642

UNIVERS HUMERAL HEAD 45/15
ARTHREX, INC.
AR-9145-15
In Commercial Distribution

  • 00888867135642 ()
  • M150AR9145151 ()
AR-9145-15

  • Uncoated shoulder humeral stem prosthesis

Arthrex® - 00888867135611

UNIVERS CA HUMERAL HEAD, 44/19
ARTHREX, INC.
AR-9144-19CA
In Commercial Distribution

  • 00888867135611 ()
  • M150AR914419CA1 ()
AR-9144-19CA

  • Uncoated shoulder humeral stem prosthesis

Arthrex® - 00888867135581

UNIVERS CA HUMERAL HEAD, 44/17
ARTHREX, INC.
AR-9144-17CA
In Commercial Distribution

  • 00888867135581 ()
  • M150AR914417CA1 ()
AR-9144-17CA

  • Uncoated shoulder humeral stem prosthesis

Arthrex® - 00888867135543

UNIVERS HUMERAL HEAD 43/15
ARTHREX, INC.
AR-9143-15
In Commercial Distribution

  • 00888867135543 ()
  • M150AR9143151 ()
AR-9143-15

  • Uncoated shoulder humeral stem prosthesis

Arthrex® - 00888867135505

UNIVERS CA HUMERAL HEAD, 42/17
ARTHREX, INC.
AR-9142-17CA
In Commercial Distribution

  • 00888867135505 ()
  • M150AR914217CA1 ()
AR-9142-17CA

  • Uncoated shoulder humeral stem prosthesis

Arthrex® - 00888867135468

UNIVERS HUMERAL HEAD 40/14
ARTHREX, INC.
AR-9140-14
In Commercial Distribution

  • 00888867135468 ()
  • M150AR9140141 ()
AR-9140-14

  • Uncoated shoulder humeral stem prosthesis

Arthrex® - 00888867135451

REPL PART, CENTRAL PEG FOR CORING REAMER
ARTHREX, INC.
AR-9127-SP
In Commercial Distribution

  • 00888867135451 ()
AR-9127-SP

  • Bone-resection orthopaedic reamer, reusable

Arthrex® - 00888867134942

REPL PART, POLY PLATE, BASEPL IMP, LARGE
ARTHREX, INC.
AR-9120D-03SP
In Commercial Distribution

  • 00888867134942 ()
AR-9120D-03SP

  • Orthopaedic implant impactor, reusable

Arthrex® - 00888867134935

REPL PART, POLY PLATE, BASEPL IMP, MED
ARTHREX, INC.
AR-9120D-02SP
In Commercial Distribution

  • 00888867134935 ()
AR-9120D-02SP

  • Orthopaedic implant impactor, reusable

Arthrex® - 00888867134928

REPL PART, POLY PLATE, BASEPL IMP, SMALL
ARTHREX, INC.
AR-9120D-01SP
In Commercial Distribution

  • 00888867134928 ()
AR-9120D-01SP

  • Orthopaedic implant impactor, reusable

Arthrex® - 00888867134881

GLENOID, POLY WITH PEG, X-LARGE
ARTHREX, INC.
AR-9105-04
In Commercial Distribution

  • 00888867134881 ()
  • M150AR9105042 ()
AR-9105-04

  • Shoulder glenoid fossa prosthesis, prefabricated

Arthrex® - 00888867134874

GLENOID, POLY WITH KEEL EXTRA LARGE
ARTHREX, INC.
AR-9104-04
In Commercial Distribution

  • 00888867134874 ()
  • M150AR9104042 ()
AR-9104-04

  • Shoulder glenoid fossa prosthesis, prefabricated

Arthrex® - 00888867134867

TRUNION KIT FOR UNIVERS II
ARTHREX, INC.
AR-9100TK
In Commercial Distribution

  • 00888867134867 ()
  • M150AR9100TK2 ()
AR-9100TK

  • Uncoated shoulder humeral stem prosthesis

Arthrex® - 00888867134836

UNIVERS APEX HUMERAL STEM, 15MM
ARTHREX, INC.
AR-9100-15S
In Commercial Distribution

  • 00888867134836 ()
  • M150AR910015S1 ()
AR-9100-15S

  • Uncoated shoulder humeral stem prosthesis

Arthrex® - 00888867134799

UNIVERS APEX HUMERAL STEM, 14MM
ARTHREX, INC.
AR-9100-14S
In Commercial Distribution

  • 00888867134799 ()
  • M150AR910014S1 ()
AR-9100-14S

  • Uncoated shoulder humeral stem prosthesis

Arthrex® - 00888867134751

UNIVERS APEX HUMERAL STEM, 13MM
ARTHREX, INC.
AR-9100-13S
In Commercial Distribution

  • 00888867134751 ()
  • M150AR910013S1 ()
AR-9100-13S

  • Uncoated shoulder humeral stem prosthesis

Arthrex® - 00888867134706

UNIVERS APEX HUMERAL STEM, 12MM
ARTHREX, INC.
AR-9100-12S
In Commercial Distribution

  • 00888867134706 ()
  • M150AR910012S1 ()
AR-9100-12S

  • Uncoated shoulder humeral stem prosthesis

Arthrex® - 00888867134676

HUMERAL STEM 12MM
ARTHREX, INC.
AR-9100-12
Not in Commercial Distribution

  • 00888867134676 ()
  • M150AR9100120 ()
AR-9100-12

  • Uncoated shoulder humeral stem prosthesis

Arthrex® - 00888867134652

UNIVERS APEX HUMERAL STEM, 11MM
ARTHREX, INC.
AR-9100-11S
In Commercial Distribution

  • 00888867134652 ()
  • M150AR910011S1 ()
AR-9100-11S

  • Uncoated shoulder humeral stem prosthesis

Arthrex® - 00888867134621

HUMERAL STEM 11MM
ARTHREX, INC.
AR-9100-11
In Commercial Distribution

  • 00888867134621 ()
  • M150AR9100111 ()
AR-9100-11

  • Uncoated shoulder humeral stem prosthesis

Arthrex® - 00888867134607

UNIVERS APEX HUMERAL STEM, 10MM
ARTHREX, INC.
AR-9100-10S
In Commercial Distribution

  • 00888867134607 ()
  • M150AR910010S1 ()
AR-9100-10S

  • Uncoated shoulder humeral stem prosthesis

Arthrex® - 00888867134553

UNIVERS APEX HUMERAL STEM, 9MM
ARTHREX, INC.
AR-9100-09S
In Commercial Distribution

  • 00888867134553 ()
  • M150AR910009S1 ()
AR-9100-09S

  • Uncoated shoulder humeral stem prosthesis

Arthrex® - 00888867134522

HUMERAL STEM 9MM
ARTHREX, INC.
AR-9100-09
Not in Commercial Distribution

  • 00888867134522 ()
  • M150AR9100090 ()
AR-9100-09

  • Uncoated shoulder humeral stem prosthesis

Arthrex® - 00888867134508

UNIVERS APEX HUMERAL STEM, 8MM
ARTHREX, INC.
AR-9100-08S
In Commercial Distribution

  • 00888867134508 ()
  • M150AR910008S1 ()
AR-9100-08S

  • Uncoated shoulder humeral stem prosthesis

Arthrex® - 00888867134478

HUMERAL STEM 8MM
ARTHREX, INC.
AR-9100-08
Not in Commercial Distribution

  • 00888867134478 ()
  • M150AR9100080 ()
AR-9100-08

  • Uncoated shoulder humeral stem prosthesis

Arthrex® - 00888867134454

UNIVERS APEX HUMERAL STEM, 7MM
ARTHREX, INC.
AR-9100-07S
In Commercial Distribution

  • 00888867134454 ()
  • M150AR910007S1 ()
AR-9100-07S

  • Uncoated shoulder humeral stem prosthesis

Arthrex® - 00888867134430

HUMERAL STEM 7MM
ARTHREX, INC.
AR-9100-07
Not in Commercial Distribution

  • 00888867134430 ()
  • M150AR9100070 ()
AR-9100-07

  • Uncoated shoulder humeral stem prosthesis

Arthrex® - 00888867134416

UNIVERS APEX HUMERAL STEM, 6MM
ARTHREX, INC.
AR-9100-06S
In Commercial Distribution

  • 00888867134416 ()
  • M150AR910006S1 ()
AR-9100-06S

  • Uncoated shoulder humeral stem prosthesis

Arthrex® - 00888867134041

CURVED MINI SCORPION DX
ARTHREX, INC.
AR-8999C
In Commercial Distribution

  • 00888867134041 ()
AR-8999C

  • Suturing unit, reusable

Arthrex® - 00888867134010

ANKLE FUSION PLATE, LATERAL TTC
ARTHREX, INC.
AR-8970TTC
In Commercial Distribution

  • 00888867134010 ()
  • M150AR8970TTC0 ()
AR-8970TTC

  • Orthopaedic fixation plate, non-bioabsorbable

Arthrex® - 00888867134003

ANKLE FUSION PLATE, LATERAL TT
ARTHREX, INC.
AR-8970TT
In Commercial Distribution

  • 00888867134003 ()
  • M150AR8970TT0 ()
AR-8970TT

  • Orthopaedic fixation plate, non-bioabsorbable

Arthrex® - 00888867133990

ANKLE FUSION PLATING SYSTEM
ARTHREX, INC.
AR-8970S
In Commercial Distribution

  • 00888867133990 ()
AR-8970S

  • Ligament reconstruction instrument set, reusable

Arthrex® - 00888867133983

LARGE AO HANDLE, RATCHETING, CANN.
ARTHREX, INC.
AR-8970RH
In Commercial Distribution

  • 00888867133983 ()
AR-8970RH

  • Surgical instrument handle, non-torque-limiting

Arthrex® - 00888867133976

ANKLE FUSION PLATE, POSTERIOR TTC, RIGHT
ARTHREX, INC.
AR-8970PR
In Commercial Distribution

  • 00888867133976 ()
  • M150AR8970PR0 ()
AR-8970PR

  • Orthopaedic fixation plate, non-bioabsorbable

Arthrex® - 00888867133969

ANKLE FUSION PLATE, POSTERIOR TTC, LEFT
ARTHREX, INC.
AR-8970PL
In Commercial Distribution

  • 00888867133969 ()
  • M150AR8970PL0 ()
AR-8970PL

  • Orthopaedic fixation plate, non-bioabsorbable

Arthrex® - 00888867133938

ANKLE FUSION PLATE, ANTERIOR TT, RIGHT
ARTHREX, INC.
AR-8970AR
In Commercial Distribution

  • 00888867133938 ()
  • M150AR8970AR0 ()
AR-8970AR

  • Orthopaedic fixation plate, non-bioabsorbable

Arthrex® - 00888867133921

ANKLE FUSION PLATE, ANTERIOR TT, LEFT
ARTHREX, INC.
AR-8970AL
In Commercial Distribution

  • 00888867133921 ()
  • M150AR8970AL0 ()
AR-8970AL

  • Orthopaedic fixation plate, non-bioabsorbable

Arthrex® - 00888867133907

DRILL BIT, 5.5MM
ARTHREX, INC.
AR-8970-55
In Commercial Distribution

  • 00888867133907 ()
AR-8970-55

  • Fluted surgical drill bit, single-use

Arthrex® - 00888867133891

DRILL BIT, 4.5MM
ARTHREX, INC.
AR-8970-45
In Commercial Distribution

  • 00888867133891 ()
AR-8970-45

  • Fluted surgical drill bit, single-use

Arthrex® - 00888867133884

CANNULATED DRILL BIT, 4.0MM
ARTHREX, INC.
AR-8970-40C
In Commercial Distribution

  • 00888867133884 ()
AR-8970-40C

  • Cannulated surgical drill bit, single-use

Arthrex® - 00888867133877

CANNULATED DRILL BIT, 3.0MM
ARTHREX, INC.
AR-8970-30C
In Commercial Distribution

  • 00888867133877 ()
AR-8970-30C

  • Fluted surgical drill bit, reusable

Arthrex® - 00888867133860

CALIBRATED DRILL BIT, 3.0MM
ARTHREX, INC.
AR-8970-30
In Commercial Distribution

  • 00888867133860 ()
AR-8970-30

  • Fluted surgical drill bit, reusable

Arthrex® - 00888867133853

OSTEOTOME, STRAIGHT, 12MM
ARTHREX, INC.
AR-8970-14
In Commercial Distribution

  • 00888867133853 ()
AR-8970-14

  • Orthopaedic osteotome

Arthrex® - 00888867133846

OSTETOME, ANGLED UP, 12MM
ARTHREX, INC.
AR-8970-13
In Commercial Distribution

  • 00888867133846 ()
AR-8970-13

  • Orthopaedic osteotome

Arthrex® - 00888867133839

CUP CURETTE, CURVED SHAFT, 6MM
ARTHREX, INC.
AR-8970-12
In Commercial Distribution

  • 00888867133839 ()
AR-8970-12

  • Bone curette, reusable

Arthrex® - 00888867133822

CUP CURETTE, STRAIGHT SHAFT, 6MM
ARTHREX, INC.
AR-8970-11
In Commercial Distribution

  • 00888867133822 ()
AR-8970-11

  • Bone curette, reusable

Arthrex® - 00888867133815

DRIVER, 3.5MM HEX, CANNULATED (AO)
ARTHREX, INC.
AR-8970-10
In Commercial Distribution

  • 00888867133815 ()
AR-8970-10

  • Orthopaedic inorganic implant inserter/extractor, reusable

Arthrex® - 00888867133808

LARGE BB-TAK, THREADED
ARTHREX, INC.
AR-8970-09T
In Commercial Distribution

  • 00888867133808 ()
  • M150AR897009T0 ()
AR-8970-09T

  • Orthopaedic intraoperative positioning pin, single-use

Arthrex® - 00888867133792

LARGE BB-TAK
ARTHREX, INC.
AR-8970-09
In Commercial Distribution

  • 00888867133792 ()
  • M150AR8970090 ()
AR-8970-09

  • Orthopaedic intraoperative positioning pin, single-use

Arthrex® - 00888867133785

115/5.5MM DEPTH MEASURING DEVICE
ARTHREX, INC.
AR-8970-07
In Commercial Distribution

  • 00888867133785 ()
AR-8970-07

  • Surgical drill guide, reusable
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