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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® - 00888867133501

GD,CALC FRAC PERCPLT,AP,STD R
ARTHREX, INC.
AR-8954-09
In Commercial Distribution

  • 00888867133501 ()
AR-8954-09

  • Surgical drill guide, reusable

Arthrex® - 00888867133495

GD,CALC FRAC PERCPLT,AP,STD L
ARTHREX, INC.
AR-8954-08
In Commercial Distribution

  • 00888867133495 ()
AR-8954-08

  • Surgical drill guide, reusable

Arthrex® - 00888867133334

VARIABLE ANGLE SCREW SET, 2.4/3.0MM
ARTHREX, INC.
AR-8950S-V1
In Commercial Distribution

  • 00888867133334 ()
AR-8950S-V1

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Arthrex® - 00888867133273

COMPREHENSIVE FIXATION SET, 2.4/3.0 MM
ARTHREX, INC.
AR-8950S-01
In Commercial Distribution

  • 00888867133273 ()
AR-8950S-01

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Arthrex® - 00888867133235

MINI JOINT DISTRACTOR INSTRUMENT SET
ARTHREX, INC.
AR-8950JDS
In Commercial Distribution

  • 00888867133235 ()
AR-8950JDS

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Arthrex® - 00888867133129

PIN INSERT, SINGLE GUIDE
ARTHREX, INC.
AR-8946-03
In Commercial Distribution

  • 00888867133129 ()
AR-8946-03

  • Surgical drill guide, reusable

Arthrex® - 00888867132320

ANKLE FRACTURE SYSTEM LID
ARTHREX, INC.
AR-8943-44C
In Commercial Distribution

  • 00888867132320 ()
AR-8943-44C

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867132313

SYNDESMOSIS CLAMP
ARTHREX, INC.
AR-8943-44
In Commercial Distribution

  • 00888867132313 ()
AR-8943-44

  • Bone approximation clamp

Arthrex® - 00888867132306

HOHMANN RETRACTOR, 15MM
ARTHREX, INC.
AR-8943-22
Not in Commercial Distribution

  • 00888867132306 ()
AR-8943-22

  • Hand-held surgical retractor, reusable

Arthrex® - 00888867132290

Depth Device, 2.7/3.5/4.0mm, Slider Asm
ARTHREX, INC.
AR-8943-15-1
In Commercial Distribution

  • 00888867132290 ()
AR-8943-15-1

  • Surgical depth gauge, reusable

Arthrex® - 00888867132153

AIM GD FIX. SCRW PLANTAR LAPIDUS PLT
ARTHREX, INC.
AR-8941AS
In Commercial Distribution

  • 00888867132153 ()
AR-8941AS

  • Surgical drill guide, reusable

Arthrex® - 00888867132146

AIM GD,RT,PLANTAR LAPIDUS PLT
ARTHREX, INC.
AR-8941AR
In Commercial Distribution

  • 00888867132146 ()
AR-8941AR

  • Surgical drill guide, reusable

Arthrex® - 00888867132139

AIM GD,LFT,PLANTAR LAPIDUS PLT
ARTHREX, INC.
AR-8941AL
In Commercial Distribution

  • 00888867132139 ()
AR-8941AL

  • Surgical drill guide, reusable

Arthrex® - 00888867131538

4.5x14mm Corkscrew FT, Disps
ARTHREX, INC.
AR-8927DSC
In Commercial Distribution

  • 10888867131535 ()
  • 00888867131538 ()
AR-8927DSC

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

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® - 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

Arthrex® - 00888867223967

4K SynergyUHD4 Trimano Camera Holder
ARTHREX, INC.
AR-3210-0011
In Commercial Distribution

  • 00888867223967 ()
AR-3210-0011

  • Surgical camera holder

Arthrex® - 00888867221383

Drill Guide for 3.5mm Screws, Special
ARTHREX, INC.
SP-4162G
In Commercial Distribution

  • 00888867221383 ()
SP-4162G

  • Surgical drill guide, reusable

Arthrex® - 00888867221222

Boney Bankart Lasso, Right
ARTHREX, INC.
SP-5068-40BBR
In Commercial Distribution

  • 00888867221222 ()
SP-5068-40BBR

  • Suturing unit, reusable

Arthrex® - 00888867221215

Boney Bankart Lasso, Left
ARTHREX, INC.
SP-5068-40BBL
In Commercial Distribution

  • 00888867221215 ()
SP-5068-40BBL

  • Suturing unit, reusable

Arthrex® - 00888867220027

T15 HEXALOBE DRIVESHAFT, SOLID, STRAIGHT
ARTHREX, INC.
AR-8950SD-15
In Commercial Distribution

  • 00888867220027 ()
AR-8950SD-15

  • Cannulated surgical drill bit, single-use

Arthrex® - 00888867219977

WRIST PLTG SYS DISTRACTOR CADDY BASE&LID
ARTHREX, INC.
AR-8916C-25
In Commercial Distribution

  • 00888867219977 ()
AR-8916C-25

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867217478

BioSync Wedge Instrumentation Set
ARTHREX, INC.
AR-8948S
In Commercial Distribution

  • 00888867217478 ()
AR-8948S

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Arthrex® - 00888867217461

BioSync Reconstruction Instrument Case
ARTHREX, INC.
AR-8948C
In Commercial Distribution

  • 00888867217461 ()
AR-8948C

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867212329

INSTRUMENT CASE, MASTER HAND
ARTHREX, INC.
AR-2200C
In Commercial Distribution

  • 00888867212329 ()
AR-2200C

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867212244

OSTEOTOMY INSTRUMENT CASE
ARTHREX, INC.
AR-13330C
In Commercial Distribution

  • 00888867212244 ()
AR-13330C

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867209282

Sizing Template for AR-2680ST
ARTHREX, INC.
AR-2680STT
In Commercial Distribution

  • 00888867209282 ()
AR-2680STT

  • Surgical implant template, reusable

Arthrex® - 00888867209268

Sizing Template for AR-2656DL/DR
ARTHREX, INC.
AR-2656DT
In Commercial Distribution

  • 00888867209268 ()
AR-2656DT

  • Surgical implant template, reusable

Arthrex® - 00888867209244

Sizing Template for AR-2654CL/CR
ARTHREX, INC.
AR-2654CT
In Commercial Distribution

  • 00888867209244 ()
AR-2654CT

  • Surgical implant template, reusable

Arthrex® - 00888867128224

K-WIRE SLEEVE, GRAFT ANCHOR
ARTHREX, INC.
AR-8826G-06
In Commercial Distribution

  • 00888867128224 ()
AR-8826G-06

  • Orthopaedic implantation sleeve, reusable

Arthrex® - 00888867126152

ANKLE CHONDRAL PICK SET
ARTHREX, INC.
AR-8655SP
In Commercial Distribution

  • 00888867126152 ()
AR-8655SP

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Arthrex® - 00888867126145

ANKLE ARTHROSCOPY INSTRUMENT SET
ARTHREX, INC.
AR-8655S
In Commercial Distribution

  • 00888867126145 ()
AR-8655S

  • Ligament reconstruction instrument set, reusable

Arthrex® - 00888867119338

UNIVERS APEX X -RAY TEMPLATES
ARTHREX, INC.
AR-705
In Commercial Distribution

  • 00888867119338 ()
AR-705

  • Surgical implant template, reusable

Arthrex® - 00888867118997

UNIVERS REVERS X-RAY TEMPLATES
ARTHREX, INC.
AR-703
In Commercial Distribution

  • 00888867118997 ()
AR-703

  • Surgical implant template, reusable

Arthrex® - 00888867118577

UNIVERS SHOULDER FRACTURE STEM X-RAY
ARTHREX, INC.
AR-700
In Commercial Distribution

  • 00888867118577 ()
AR-700

  • Surgical implant template, reusable

Arthrex® - 00888867116801

IBALANCE TKA, 2.45" HEADED THREADED PIN
ARTHREX, INC.
AR-613-72
In Commercial Distribution

  • 00888867116801 ()
AR-613-72

  • Surgical drill guide, reusable

Arthrex® - 00888867116788

IBALANCE TKA, 3" HEADLESS THREADED PIN
ARTHREX, INC.
AR-613-7
In Commercial Distribution

  • 00888867116788 ()
AR-613-7

  • Surgical drill guide, reusable

Arthrex® - 00888867116740

iBALANCE TKA, CURVED OSTEOTOME
ARTHREX, INC.
AR-613-66
In Commercial Distribution

  • 00888867116740 ()
AR-613-66

  • Orthopaedic osteotome

Arthrex® - 00888867111417

IBAL PFJ,POST REFERENCING GD
ARTHREX, INC.
AR-602-7
Not in Commercial Distribution

  • 00888867111417 ()
AR-602-7

  • Surgical drill guide, reusable

Arthrex® - 00888867111301

UKA TIBIA CUT CORRECTION GUIDE, 2MM
ARTHREX, INC.
AR-601-TCCG-2
In Commercial Distribution

  • 00888867111301 ()
AR-601-TCCG-2

  • Surgical drill guide, reusable

Arthrex® - 00888867110939

RPLCMT KEY FOR JACOBS CHUCK FOR AR-600
ARTHREX, INC.
AR-600KEY
In Commercial Distribution

  • 00888867110939 ()
AR-600KEY

  • Surgical drill chuck key

Arthrex® - 00888867256972

5TH METATARSAL CADDY REPLACEMENT POLYPRO
ARTHREX, INC.
AR-8956C-SC-01
In Commercial Distribution

  • 00888867256972 ()
AR-8956C-SC-01

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867256668

Uni Revers Superolateral Version Downrod
ARTHREX, INC.
AR-9507RGSL-3
In Commercial Distribution

  • 00888867256668 ()
AR-9507RGSL-3

  • Surgical depth gauge, reusable

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® - 00888867255487

TROCHLEA GUIDE HANDLE
ARTHREX, INC.
AR-4011
In Commercial Distribution

  • 00888867255487 ()
AR-4011

  • Surgical instrument handle, non-torque-limiting

Arthrex® - 00888867255340

TROCHLEA GUIDE ASSEMBLY, 35MM BASE
ARTHREX, INC.
AR-4050-35
In Commercial Distribution

  • 00888867255340 ()
AR-4050-35

  • Surgical drill guide, reusable

Arthrex® - 00888867255333

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

  • 00888867255333 ()
AR-4050-30

  • Surgical drill guide, reusable
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