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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® - 00888867138438

RICHARDSON RETRTR,1"WX 1.5"DX9.5"L
ARTHREX, INC.
AR-9260-40
In Commercial Distribution

  • 00888867138438 ()
AR-9260-40

  • Hand-held surgical retractor, reusable

Integra® Jarit® - 10381780403401

Barany Noise Apparatus with Hard Rubber Ear Tip
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
X2089
Not in Commercial Distribution

  • M274X20891 ()
  • 10381780403401 ()
X2089

  • Audiometric-evaluation noise system

Integra® Jarit® - 10381780400448

Integra® Jarit® Olsen-Hegar Needle Holder & Scissors, 5-3/4", Tungsten Carbide, Smooth Jaws
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
P3160
In Commercial Distribution

  • M274P31601 ()
  • 10381780400448 ()

  • 5-3/4"
P3160

  • Suturing needle holder, reusable

Arthrex® - 00888867230828

Depth Device, f/ 1.35mm Wire Sleeve
ARTHREX, INC.
AR-8963-09
In Commercial Distribution

  • 00888867230828 ()
AR-8963-09

  • Surgical depth gauge, reusable

Arthrex® - 00888867230811

2.7mm Threaded Drill Guide, 10-60mm
ARTHREX, INC.
AR-8963-08
In Commercial Distribution

  • 00888867230811 ()
AR-8963-08

  • Surgical drill guide, reusable

Arthrex® - 00888867230798

Wire Sleeve Insert, 1.35mm
ARTHREX, INC.
AR-8963-03
In Commercial Distribution

  • 00888867230798 ()
AR-8963-03

  • Surgical drill guide, reusable

Arthrex® - 00888867230767

2.7MM STRAIGHT PLATE CADDY & LID
ARTHREX, INC.
AR-8963C-02
In Commercial Distribution

  • 00888867230767 ()
AR-8963C-02

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867230743

DISTAL TIBIA PLATING CASE
ARTHREX, INC.
AR-8963C
In Commercial Distribution

  • 00888867230743 ()
AR-8963C

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867229389

Hamstring Donor Site Delivery Tube
ARTHREX, INC.
AR-1280
In Commercial Distribution

  • 10888867229386 ()
  • 00888867229389 ()
AR-1280

  • Orthopaedic graft inserter, reusable

Arthrex® - 00888867229365

2.7mm Insertion Handle, QC
ARTHREX, INC.
AR-8963-07
In Commercial Distribution

  • 00888867229365 ()
AR-8963-07

  • Orthopaedic inorganic implant inserter/extractor, reusable

Arthrex® - 00888867227958

LASSO, LG CURVE, STRAIGHT
ARTHREX, INC.
SP-5068-LGS
In Commercial Distribution

  • 00888867227958 ()
SP-5068-LGS

  • Suturing unit, reusable

Arthrex® - 00888867226982

UNI CA HUMERAL HEADS X-RAY TEMPLATES
ARTHREX, INC.
AR-706
In Commercial Distribution

  • 00888867226982 ()
AR-706

  • Surgical implant template, reusable

Arthrex® - 00888867226128

iBalance, Patella Drill Guide Combo
ARTHREX, INC.
AR-602-49
In Commercial Distribution

  • 00888867226128 ()
AR-602-49

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

Arthrex® - 00888867226074

DISTAL TIBIA ALLOGRAFT WORKSTATION CASE
ARTHREX, INC.
AR-7001C
In Commercial Distribution

  • 00888867226074 ()
AR-7001C

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867226067

2.8MM CANNULATED DRILL GUIDE, X-LARGE
ARTHREX, INC.
AR-9215-8CG
In Commercial Distribution

  • 00888867226067 ()
AR-9215-8CG

  • Surgical drill guide, reusable

Arthrex® - 00888867225855

Low Profile Screw Case Tray Insert 3
ARTHREX, INC.
AR-8946HC
In Commercial Distribution

  • 00888867225855 ()
AR-8946HC

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867225077

Instrument Case, Rev CA Head & Adptr Trl
ARTHREX, INC.
AR-9501HC-RCAC
In Commercial Distribution

  • 00888867225077 ()
AR-9501HC-RCAC

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867224049

Arthroscopic IB Guidewire
ARTHREX, INC.
SP-1678K
In Commercial Distribution

  • 00888867224049 ()
SP-1678K

  • Wire/ligature passer, single-use

Arthrex® - 00888867223998

Arthroscopic IB Guidewire Sleeve
ARTHREX, INC.
SP-1678C-02
In Commercial Distribution

  • 00888867223998 ()
SP-1678C-02

  • Surgical drill guide, reusable

Arthrex® - 00888867223974

FIBERWIRE CART
ARTHREX, INC.
AR-7200CART
In Commercial Distribution

  • 00888867223974 ()
AR-7200CART

  • Electromechanical device/system transport trolley
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