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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® - 00888867138292

UNIVERS II CONGRUENT GLENOID RMR,56MM
ARTHREX, INC.
AR-9256RR
In Commercial Distribution

  • 00888867138292 ()
AR-9256RR

  • Fluted surgical drill bit, reusable

Arthrex® - 00888867138247

UNIVERS II CONGRUENT GLENOID RMR,54MM
ARTHREX, INC.
AR-9254RR
In Commercial Distribution

  • 00888867138247 ()
AR-9254RR

  • Fluted surgical drill bit, reusable

Arthrex® - 00888867138209

UNIVERS II CONGRUENT GLENOID RMR,52MM
ARTHREX, INC.
AR-9252RR
In Commercial Distribution

  • 00888867138209 ()
AR-9252RR

  • Fluted surgical drill bit, reusable

Arthrex® - 00888867138179

UNIVERS II CONGRUENT GLENOID RMR,50MM
ARTHREX, INC.
AR-9250RR
In Commercial Distribution

  • 00888867138179 ()
AR-9250RR

  • Fluted surgical drill bit, reusable

Arthrex® - 00888867138148

UNIVERS II CONGRUENT GLENOID RMR,48MM
ARTHREX, INC.
AR-9248RR
In Commercial Distribution

  • 00888867138148 ()
AR-9248RR

  • Fluted surgical drill bit, reusable

Arthrex® - 00888867138117

UNIVERS II CONGRUENT GLENOID RMR,46MM
ARTHREX, INC.
AR-9246RR
In Commercial Distribution

  • 00888867138117 ()
AR-9246RR

  • Fluted surgical drill bit, reusable

Arthrex® - 00888867138070

UNIVERS II CONGRUENT GLENOID RMR,44MM
ARTHREX, INC.
AR-9244RR
In Commercial Distribution

  • 00888867138070 ()
AR-9244RR

  • Fluted surgical drill bit, reusable

Arthrex® - 00888867138049

UNIVERS II CONGRUENT GLENOID RMR,42MM
ARTHREX, INC.
AR-9242RR
In Commercial Distribution

  • 00888867138049 ()
AR-9242RR

  • Fluted surgical drill bit, reusable

Arthrex® - 00888867138025

UNIVERS II CONGRUENT RMR GLOVE PROTECTOR
ARTHREX, INC.
AR-9240RRH
In Commercial Distribution

  • 00888867138025 ()
AR-9240RRH

  • Surgical drill guide, reusable

Arthrex® - 00888867138018

UNIVERS II CONGRUENT GLENOID RMR,40MM
ARTHREX, INC.
AR-9240RR
In Commercial Distribution

  • 00888867138018 ()
AR-9240RR

  • Bone-resection orthopaedic reamer, reusable

Arthrex® - 00888867137493

PIN SET, UNIVERS II/ ECLIPSE
ARTHREX, INC.
AR-9207S
In Commercial Distribution

  • 00888867137493 ()
AR-9207S

  • Orthopaedic intraoperative positioning pin, single-use

Arthrex® - 00888867137097

UNIVERS II CONGRUENT RMR INSTR CS
ARTHREX, INC.
AR-9200RRC
In Commercial Distribution

  • 00888867137097 ()
AR-9200RRC

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867137073

UNIVERS CA HUMERAL HEAD INSTRUMENT CASE
ARTHREX, INC.
AR-9200CAC
In Commercial Distribution

  • 00888867137073 ()
AR-9200CAC

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867407534

Talus Allograft OATS Workstation Case
ARTHREX, INC.
AR-8902C
In Commercial Distribution

  • 00888867407534 ()
AR-8902C

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867406018

Point-to-Point Meniscal Marking Hook
ARTHREX, INC.
AR-1610H
In Commercial Distribution

  • 00888867406018 ()
AR-1610H

  • Soft-tissue surgical hook, reusable

Arthrex® - 00888867405608

Univers Revers Humeral Inst, Case 2
ARTHREX, INC.
AR-9501H-2C
In Commercial Distribution

  • 00888867405608 ()
AR-9501H-2C

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867405592

Univers Revers Humeral Inst, Case 1
ARTHREX, INC.
AR-9501H-1C
In Commercial Distribution

  • 00888867405592 ()
AR-9501H-1C

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867405295

Talus Allograft OATS Instrument Case
ARTHREX, INC.
AR-8901C
In Commercial Distribution

  • 00888867405295 ()
AR-8901C

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867403239

3.5MM LOCK COMPRESSION PLT, OUTER CASE
ARTHREX, INC.
AR-7657C
In Commercial Distribution

  • 00888867403239 ()
AR-7657C

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867403222

DIST FIBULA PLT SS / 3.5MM LCP SS, CADDY
ARTHREX, INC.
AR-8943C-PC-02
In Commercial Distribution

  • 00888867403222 ()
AR-8943C-PC-02

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867403215

3.5MM LOCK COMPR PLT SS, TRAY INSERT
ARTHREX, INC.
AR-8657C-01
In Commercial Distribution

  • 00888867403215 ()
AR-8657C-01

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867403208

3.5MM LOCK COMPR PLT TI, TRAY INSERT
ARTHREX, INC.
AR-7657C-01
In Commercial Distribution

  • 00888867403208 ()
AR-7657C-01

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867381469

Mini CFS, Instr Case Split Style
ARTHREX, INC.
AR-18700CS
In Commercial Distribution

  • 00888867381469 ()
AR-18700CS

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867380837

DRILL GUIDE, 1.24/3.7MM
ARTHREX, INC.
AR-8925DG
In Commercial Distribution

  • 00888867380837 ()
AR-8925DG

  • Surgical drill guide, reusable

Arthrex® - 00888867379770

Mini CFS Instr Case, Split Style - Lid
ARTHREX, INC.
AR-18700CS-03
In Commercial Distribution

  • 00888867379770 ()
AR-18700CS-03

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867379763

Mini CFS, Instr Case, Split - Instr Tray
ARTHREX, INC.
AR-18700CS-02
In Commercial Distribution

  • 00888867379763 ()
AR-18700CS-02

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867379756

Mini CFS, Instr Case, Split - Caddy Tray
ARTHREX, INC.
AR-18700CS-01
In Commercial Distribution

  • 00888867379756 ()
AR-18700CS-01

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867377400

ANKLE & FRACTURE SYS SCREW CADDY
ARTHREX, INC.
AR-8943C-SC1
In Commercial Distribution

  • 00888867377400 ()
AR-8943C-SC1

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867377394

ANKLE & FRACTURE SYS PLATE CADDY
ARTHREX, INC.
AR-8943C-PC1
In Commercial Distribution

  • 00888867377394 ()
AR-8943C-PC1

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867377387

ANKLE & FRACTURE SYS INSTR CASE
ARTHREX, INC.
AR-8943C-1
In Commercial Distribution

  • 00888867377387 ()
AR-8943C-1

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867370036

2.4MM 3H AND 5H VOLAR PLT CADDY
ARTHREX, INC.
AR-8916C-30
In Commercial Distribution

  • 00888867370036 ()
AR-8916C-30

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867370029

2.4MM VOLAR DIST RAD PLT SYS CADDY, LID
ARTHREX, INC.
AR-8924C-02
In Commercial Distribution

  • 00888867370029 ()
AR-8924C-02

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867370012

2.4MM VOLAR DIST RAD PLT SYS CADDY
ARTHREX, INC.
AR-8924C-01
In Commercial Distribution

  • 00888867370012 ()
AR-8924C-01

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867370005

2.4MM VOLAR DIST RAD PLT SYS CASE
ARTHREX, INC.
AR-8924C
In Commercial Distribution

  • 00888867370005 ()
AR-8924C

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867368293

TI PL DISTAL FIBULA / HOOK PLATE CADDY
ARTHREX, INC.
AR-9943C-PC-01
In Commercial Distribution

  • 00888867368293 ()
AR-9943C-PC-01

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867368286

ANKLE & FRACTURE SYS SCREW CADDY, TI
ARTHREX, INC.
AR-9943C-SC1
In Commercial Distribution

  • 00888867368286 ()
AR-9943C-SC1

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867368279

ANKLE & FRACTURE SYS INSTR CASE, TI
ARTHREX, INC.
AR-9943C-1
In Commercial Distribution

  • 00888867368279 ()
AR-9943C-1

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867367555

Beveled FT and Compression FT Scrw Caddy
ARTHREX, INC.
AR-8741C-01
In Commercial Distribution

  • 00888867367555 ()
AR-8741C-01

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867367548

Minimally Invasive Bunion Corr System
ARTHREX, INC.
AR-8741C
In Commercial Distribution

  • 00888867367548 ()
AR-8741C

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867364356

Percutaneous Insertion Handle, 4.5mm
ARTHREX, INC.
AR-8963-24
In Commercial Distribution

  • 00888867364356 ()
AR-8963-24

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

Arthrex® - 00888867364349

Lag Drill Guide, 3.5 mm / 2.5 mm
ARTHREX, INC.
AR-8963-21
In Commercial Distribution

  • 00888867364349 ()
AR-8963-21

  • Surgical drill guide, reusable

Arthrex® - 00888867364332

Cup Curette, 9mm
ARTHREX, INC.
AR-8963-18
In Commercial Distribution

  • 00888867364332 ()
AR-8963-18

  • Bone curette, reusable

Arthrex® - 00888867364325

Chisel, Straight, 7mm
ARTHREX, INC.
AR-8963-17
In Commercial Distribution

  • 00888867364325 ()
AR-8963-17

  • Orthopaedic osteotome

Arthrex® - 00888867364318

Chisel, Curved, 7mm
ARTHREX, INC.
AR-8963-16
In Commercial Distribution

  • 00888867364318 ()
AR-8963-16

  • Orthopaedic osteotome

Arthrex® - 00888867364301

Chisel, Curved, 14mm
ARTHREX, INC.
AR-8963-15
In Commercial Distribution

  • 00888867364301 ()
AR-8963-15

  • Orthopaedic osteotome

Arthrex® - 00888867364295

Chisel, Straight, 14mm
ARTHREX, INC.
AR-8963-14
In Commercial Distribution

  • 00888867364295 ()
AR-8963-14

  • Orthopaedic osteotome

Arthrex® - 00888867364257

Primary Pilon Fusion Screw Caddy, Lid
ARTHREX, INC.
AR-8963C-SC-01
In Commercial Distribution

  • 00888867364257 ()
AR-8963C-SC-01

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867364240

Primary Pilon Fusion Screw Caddy
ARTHREX, INC.
AR-8963C-SC
In Commercial Distribution

  • 00888867364240 ()
AR-8963C-SC

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867364233

Primary Pilon Fusion Case, Lid
ARTHREX, INC.
AR-8963C-04
In Commercial Distribution

  • 00888867364233 ()
AR-8963C-04

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867364226

Primary Pilon Fusion Case
ARTHREX, INC.
AR-8963C-03
In Commercial Distribution

  • 00888867364226 ()
AR-8963C-03

  • Device sterilization/disinfection container, reusable
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