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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® - 00888867235793

iBal UKA, Vertical Cut Guide, Left
ARTHREX, INC.
AR-611-TRLV
In Commercial Distribution

  • 00888867235793 ()
AR-611-TRLV

  • Surgical drill guide, reusable

Arthrex® - 00888867235762

iBalance Patella Protector, Medium
ARTHREX, INC.
AR-623-42
In Commercial Distribution

  • 00888867235762 ()
AR-623-42

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

Arthrex® - 00888867235694

CHONDRALDRILL™, HIP, DRILL GUIDE
ARTHREX, INC.
AR-6585
In Commercial Distribution

  • 00888867235694 ()
AR-6585

  • Surgical drill guide, reusable

Arthrex® - 00888867235380

iBalance TKA, Stem Ext. Reamer, 15mm
ARTHREX, INC.
AR-623-15
In Commercial Distribution

  • 00888867235380 ()
AR-623-15

  • Orthopaedic reamer guide

Arthrex® - 00888867235366

iBalance TKA, Stem Ext. Reamer, 13mm
ARTHREX, INC.
AR-623-13
In Commercial Distribution

  • 00888867235366 ()
AR-623-13

  • Orthopaedic reamer guide

Arthrex® - 00888867235342

iBalance TKA, Stem Ext. Reamer, 11mm
ARTHREX, INC.
AR-623-11
In Commercial Distribution

  • 00888867235342 ()
AR-623-11

  • Orthopaedic reamer guide

Arthrex® - 00888867235328

SOFT TISSUE CLAMP, GRAFTPRO
ARTHREX, INC.
AR-2950SC
In Commercial Distribution

  • 00888867235328 ()
AR-2950SC

  • Tendon/ligament graft preparation station post

Arthrex® - 00888867234154

Submuscular Tissue Elevator, Dist Tibia
ARTHREX, INC.
AR-8963-10
In Commercial Distribution

  • 00888867234154 ()
AR-8963-10

  • Bone lever/elevator, reusable

Arthrex® - 00888867233843

OVER-THE-WIRE DEPTH GAUGE
ARTHREX, INC.
AR-5050-02
In Commercial Distribution

  • 00888867233843 ()
AR-5050-02

  • Surgical depth gauge, reusable

Arthrex® - 00888867233836

AO PULL RELEASE RATCHETING DRIVER
ARTHREX, INC.
AR-5050-03
In Commercial Distribution

  • 00888867233836 ()
AR-5050-03

  • Surgical instrument handle, non-torque-limiting
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