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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® - 00888867256651

iBALANCE TKA, FEMORAL SIZER, 0-7 DEG
ARTHREX, INC.
AR-623-63
In Commercial Distribution

  • 00888867256651 ()
AR-623-63

  • Surgical implant template, reusable

Arthrex® - 00888867256644

iBALANCE TKA, FEMORAL SIZER, 3 DEG
ARTHREX, INC.
AR-623-61
In Commercial Distribution

  • 00888867256644 ()
AR-623-61

  • Surgical implant template, reusable

Arthrex® - 00888867255333

TROCHLEA GUIDE ASSEMBLY, 30MM BASE
ARTHREX, INC.
AR-4050-30
In Commercial Distribution

  • 00888867255333 ()
AR-4050-30

  • Surgical drill guide, reusable

Arthrex® - 00888867255296

PLATE CADDY, TITANIUM, ANKLE FRAC SYS
ARTHREX, INC.
AR-9943C-PC
In Commercial Distribution

  • 00888867255296 ()
AR-9943C-PC

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867252561

KF Sutr Rtrvr/Grspr NR Hdl w/FlushPort
ARTHREX, INC.
AR-13970NRF
In Commercial Distribution

  • 00888867252561 ()
AR-13970NRF

  • Suturing unit, reusable

Arthrex® - 00888867252547

FiberTape Ctr, w/FlushPort
ARTHREX, INC.
AR-13250F
In Commercial Distribution

  • 00888867252547 ()
AR-13250F

  • Suture cutter, reusable

Arthrex® - 00888867252462

Grspr, Mini, 2.75 Str SR Hdl w/FlushPort
ARTHREX, INC.
AR-11900SRF
In Commercial Distribution

  • 00888867252462 ()
AR-11900SRF

  • Suturing unit, reusable

Arthrex® - 00888867252455

BB, 45 Up Tp, w/FlushPort
ARTHREX, INC.
AR-11800F
In Commercial Distribution

  • 00888867252455 ()
AR-11800F

  • Suturing unit, reusable

Arthrex® - 00888867252448

SC, 4.2 Opn Endd, Lft Ntch, w/FlushPort
ARTHREX, INC.
AR-11794LF
In Commercial Distribution

  • 00888867252448 ()
AR-11794LF

  • Suture cutter, reusable

Arthrex® - 00888867252431

2-0 SC, 2.75, Str, w/FlushPort
ARTHREX, INC.
AR-11790F
In Commercial Distribution

  • 00888867252431 ()
AR-11790F

  • Suture cutter, reusable

Arthrex® - 00888867252424

Grspr, Algtr 2.75 Str SR Hdl w/FlushPort
ARTHREX, INC.
AR-11600SRF
In Commercial Distribution

  • 00888867252424 ()
AR-11600SRF

  • Suturing unit, reusable

Arthrex® - 00888867252417

Pnch, Lg 15 Up Tp, 2.75 Str, w/FlushPort
ARTHREX, INC.
AR-11250F
In Commercial Distribution

  • 00888867252417 ()
AR-11250F

  • Orthopaedic implant impactor, reusable

Arthrex® - 00888867252400

Punch, Std Str Tp, 2.75 Str, w/FlushPort
ARTHREX, INC.
AR-11000F
In Commercial Distribution

  • 00888867252400 ()
AR-11000F

  • Orthopaedic implant impactor, reusable

Arthrex® - 00888867251946

PARS ACHILLES CASE RETROFIT BRACKETS
ARTHREX, INC.
AR-8860C-1
In Commercial Distribution

  • 00888867251946 ()
AR-8860C-1

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867251304

PORTAL SKID
ARTHREX, INC.
AR-4505
In Commercial Distribution

  • 10888867251301 ()
  • 00888867251304 ()
AR-4505

  • Endoscopic-access dilator, single-use

Arthrex® - 00888867250840

HIP ARTHROSCOPY ACCESSORIES CASE
ARTHREX, INC.
AR-6518C
In Commercial Distribution

  • 00888867250840 ()
AR-6518C

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867247741

2.9 mm Hip PushLock Disposables Kit
ARTHREX, INC.
AR-2923DHS
In Commercial Distribution

  • 00888867247741 ()
AR-2923DHS

  • Orthopaedic surgical procedure kit, non-medicated, single-use

ELEOS™ - B278K0051124E0

STABILIZING COLLET 24MM
ONKOS SURGICAL, INC.
K0051124E
In Commercial Distribution

  • B278K0051124E0 ()
K0051124E

  • General internal orthopaedic fixation system implantation kit

ELEOS™ - B278K0051122E0

STABILIZING COLLET 22MM
ONKOS SURGICAL, INC.
K0051122E
In Commercial Distribution

  • B278K0051122E0 ()
K0051122E

  • General internal orthopaedic fixation system implantation kit

ELEOS™ - B278K0051120E0

STABILIZING COLLET 20MM
ONKOS SURGICAL, INC.
K0051120E
In Commercial Distribution

  • B278K0051120E0 ()
K0051120E

  • General internal orthopaedic fixation system implantation kit

ELEOS™ - B278K0051118E0

STABILIZING COLLET 18MM
ONKOS SURGICAL, INC.
K0051118E
In Commercial Distribution

  • B278K0051118E0 ()
K0051118E

  • General internal orthopaedic fixation system implantation kit

ELEOS™ - B278K0051116E0

STABILIZING COLLET 16MM
ONKOS SURGICAL, INC.
K0051116E
In Commercial Distribution

  • B278K0051116E0 ()
K0051116E

  • General internal orthopaedic fixation system implantation kit

Arthrex® - 00888867035942

PARALLEL PIN GUIDE
ARTHREX, INC.
AR-5503
In Commercial Distribution

  • 00888867035942 ()
AR-5503

  • Suturing unit, single-use

Arthrex® - 00888867035904

FIBULAR MARKING HOOK
ARTHREX, INC.
AR-5500
In Commercial Distribution

  • 00888867035904 ()
AR-5500

  • Soft-tissue surgical hook, reusable

Arthrex® - 00888867035836

INSERTER, 8/9 MM, GRAFTBOLT
ARTHREX, INC.
AR-5104
In Commercial Distribution

  • 00888867035836 ()
AR-5104

  • Orthopaedic inorganic implant inserter/extractor, reusable

Arthrex® - 00888867035829

INSERTER, 7MM,GRAFTBOLT
ARTHREX, INC.
AR-5103
In Commercial Distribution

  • 00888867035829 ()
AR-5103

  • Orthopaedic inorganic implant inserter/extractor, reusable

Arthrex® - 00888867035812

REMOVAL TOOL, GRAFTBOLT
ARTHREX, INC.
AR-5102
In Commercial Distribution

  • 00888867035812 ()
AR-5102

  • Orthopaedic inorganic implant inserter/extractor, reusable

Arthrex® - 00888867035805

INSERTER, 10MM, GRAFTBOLT
ARTHREX, INC.
AR-5101
In Commercial Distribution

  • 00888867035805 ()
AR-5101

  • Orthopaedic inorganic implant inserter/extractor, reusable

Arthrex® - 00888867035799

GRAFTBOLT INSTRUMENT CASE INSERT
ARTHREX, INC.
AR-5100C-01
In Commercial Distribution

  • 00888867035799 ()
AR-5100C-01

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867035782

GRAFTBOLT INSTRUMENT CASE
ARTHREX, INC.
AR-5100C
In Commercial Distribution

  • 00888867035782 ()
AR-5100C

  • Device sterilization/disinfection container, reusable
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