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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® - 00888867015852

NEEDLEPUNCH II PUSHROD
ARTHREX, INC.
AR-13981P
In Commercial Distribution

  • 00888867015852 ()
AR-13981P

  • Suturing unit, reusable

Arthrex® - 00888867015722

FIBERCHAIN GRASPER W/ SR HANDLE
ARTHREX, INC.
AR-13950SR
In Commercial Distribution

  • 00888867015722 ()
AR-13950SR

  • Suturing unit, reusable

Arthrex® - 00888867013353

TISSUE ELEVATOR, 30 DEG UP, STANDARD
ARTHREX, INC.
AR-1344SE-30
In Commercial Distribution

  • 00888867013353 ()
AR-1344SE-30

  • Bone lever/elevator, reusable

Arthrex® - 00888867013346

TISSUE ELEVATOR, 15 DEG UP, STANDARD
ARTHREX, INC.
AR-1344SE-15
In Commercial Distribution

  • 00888867013346 ()
AR-1344SE-15

  • Bone lever/elevator, reusable

Arthrex® - 00888867013285

TISSUE ELEVATOR INSTRUMENT CASE
ARTHREX, INC.
AR-1344C
In Commercial Distribution

  • 00888867013285 ()
AR-1344C

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867013223

TISSUE ELEVATOR, 30 DEG DOWN
ARTHREX, INC.
AR-1344-30
In Commercial Distribution

  • 00888867013223 ()
AR-1344-30

  • Bone lever/elevator, reusable

Arthrex® - 00888867013193

TISS ELEVTR,15°DOWN-30°LFT
ARTHREX, INC.
AR-1344-1530L
In Commercial Distribution

  • 00888867013193 ()
AR-1344-1530L

  • Bone lever/elevator, reusable

Arthrex® - 00888867013186

TISSUE ELEVATOR, 15 DEG DOWN
ARTHREX, INC.
AR-1344-15
In Commercial Distribution

  • 00888867013186 ()
AR-1344-15

  • Bone lever/elevator, reusable

Arthrex® - 00888867013087

ANCHOR TAP GUIDE
ARTHREX, INC.
AR-13436
In Commercial Distribution

  • 00888867013087 ()
AR-13436

  • Surgical drill guide, reusable

Arthrex® - 00888867012967

CORRECTION GUIDE LG/XL
ARTHREX, INC.
AR-13431-02
In Commercial Distribution

  • 00888867012967 ()
AR-13431-02

  • Surgical drill guide, reusable

Arthrex® - 00888867012950

CORRECTION GUIDE SM/MD
ARTHREX, INC.
AR-13431-01
In Commercial Distribution

  • 00888867012950 ()
AR-13431-01

  • Surgical drill guide, reusable

Arthrex® - 00888867012660

FIXATION PIN
ARTHREX, INC.
AR-13422
In Commercial Distribution

  • 00888867012660 ()
AR-13422

  • Fluted surgical drill bit, reusable

Arthrex® - 00888867012561

ELEVATOR, 15 DEGREE SHOULDER TISSUE
ARTHREX, INC.
AR-1342-15
In Commercial Distribution

  • 00888867012561 ()
AR-1342-15

  • Bone lever/elevator, reusable

Arthrex® - 00888867012486

ALIGNMENT HANDLE
ARTHREX, INC.
AR-13418
In Commercial Distribution

  • 00888867012486 ()
AR-13418

  • Surgical drill guide, reusable

Arthrex® - 00888867012462

HTO FREECUT TECH KEYHOLE GD,MED
ARTHREX, INC.
AR-13417M
In Commercial Distribution

  • 00888867012462 ()
AR-13417M

  • Surgical drill guide, reusable

Arthrex® - 00888867012455

HTO FREECUT TECH KEYHOLE GD,LG
ARTHREX, INC.
AR-13417L
In Commercial Distribution

  • 00888867012455 ()
AR-13417L

  • Surgical drill guide, reusable

Arthrex® - 00888867012448

KEYHOLE GUIDE, RIGHT
ARTHREX, INC.
AR-13417-02
In Commercial Distribution

  • 00888867012448 ()
AR-13417-02

  • Surgical drill guide, reusable

Arthrex® - 00888867012431

KEYHOLE GUIDE, LEFT
ARTHREX, INC.
AR-13417-01
In Commercial Distribution

  • 00888867012431 ()
AR-13417-01

  • Surgical drill guide, reusable

Arthrex® - 00888867012325

POSTERIOR ELEVATOR
ARTHREX, INC.
AR-13411-02
In Commercial Distribution

  • 00888867012325 ()
AR-13411-02

  • Bone lever/elevator, reusable

Arthrex® - 00888867012318

COBB ELEVATOR
ARTHREX, INC.
AR-13411-01
In Commercial Distribution

  • 00888867012318 ()
AR-13411-01

  • Bone lever/elevator, reusable

Arthrex® - 00888867011960

ACL/PCL GRAFT PASSING FORCEPS W/WB
ARTHREX, INC.
AR-13400W
In Commercial Distribution

  • 00888867011960 ()
AR-13400W

  • Suturing unit, reusable

Arthrex® - 00888867011915

ACL/PCL GRAFT PASS FORFORCEP,NON-RATCHET
ARTHREX, INC.
AR-13400NR
In Commercial Distribution

  • 00888867011915 ()
AR-13400NR

  • Suturing unit, reusable

Arthrex® - 00888867011663

iBALANCE INSTRUMENT CASE
ARTHREX, INC.
AR-13400C
In Commercial Distribution

  • 00888867011663 ()
AR-13400C

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867007239

GUIDE PIN W/ SUTURE EYE 2.4 MM X 435 MM
ARTHREX, INC.
AR-1297LS
In Commercial Distribution

  • 00888867007239 ()
AR-1297LS

  • Fluted surgical drill bit, single-use

Arthrex® - 00888867007109

NDL,SUTRING,NIT W/WIRE LOOP END
ARTHREX, INC.
AR-1291S
In Commercial Distribution

  • 10888867007106 ()
  • 00888867007109 ()
AR-1291S

  • Suturing needle, single-use

Arthrex® - 00888867007093

NEEDLE, SUTURING, GRAFT PREPARATION
ARTHREX, INC.
AR-1291-4
In Commercial Distribution

  • 10888867007090 ()
  • 00888867007093 ()
AR-1291-4

  • Suturing needle, single-use

Arthrex® - 00888867006935

HAMSTRING HARVESTING INSTRUMENT CASE
ARTHREX, INC.
AR-1279C
In Commercial Distribution

  • 00888867006935 ()
AR-1279C

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867006928

MINIMALLY INVASIVE GRAFT HARVESTER, OPEN
ARTHREX, INC.
AR-1278PL
In Commercial Distribution

  • 00888867006928 ()
AR-1278PL

  • Tendon stripper

Arthrex® - 00888867006812

PCL TOOLBOX CASE
ARTHREX, INC.
AR-1269C
In Commercial Distribution

  • 00888867006812 ()
AR-1269C

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867006522

SUTR RETRIEVR,3.4MM 15°UP CRVD W/WB
ARTHREX, INC.
AR-12550W
In Commercial Distribution

  • 00888867006522 ()
AR-12550W

  • Suturing unit, reusable
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