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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® - 00888867184176

CANNULA BENDING TOOL,8G/4.3MM+10G/3.5MM
ARTHREX, INC.
AR-6655
In Commercial Distribution

  • 00888867184176 ()
AR-6655

  • Manual orthopaedic bender, reusable

Arthrex® - 00888867184107

Univers Revers Humeral Case(2of2)
ARTHREX, INC.
AR-9501HC-2
In Commercial Distribution

  • 00888867184107 ()
AR-9501HC-2

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867184091

Univers Revers Humeral Case(1of2)
ARTHREX, INC.
AR-9501HC-1
In Commercial Distribution

  • 00888867184091 ()
AR-9501HC-1

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867183827

HOHMANN RETRTR,10 1/2" LGX 24MM BLD,RND
ARTHREX, INC.
AR-9260-35
In Commercial Distribution

  • 00888867183827 ()
AR-9260-35

  • Hand-held surgical retractor, reusable

Arthrex® - 00888867177628

DRIVER, T8 HEXALOBE SELF RETAINING
ARTHREX, INC.
AR-8916-27
In Commercial Distribution

  • 00888867177628 ()
AR-8916-27

  • Orthopaedic inorganic implant inserter/extractor, reusable

Arthrex® - 00888867175136

Suture Cutter, Top Release
ARTHREX, INC.
SP-12250-1
In Commercial Distribution

  • 00888867175136 ()
SP-12250-1

  • General-purpose surgical scissors, reusable

Arthrex® - 00888867153172

Hamstring Donor Site Delivery Tube
ARTHREX, INC.
AR-1280-1
In Commercial Distribution

  • 00888867153172 ()
AR-1280-1

  • Orthopaedic graft inserter, reusable

Arthrex® - 00888867141636

Univers Revers Reduction Helper
ARTHREX, INC.
AR-9545
In Commercial Distribution

  • 00888867141636 ()
AR-9545

  • Surgical depth gauge, reusable

Arthrex® - 00888867140462

UNIVERS REVS REVISION SSTEM INSTR CS
ARTHREX, INC.
AR-9501RHC
In Commercial Distribution

  • 00888867140462 ()
AR-9501RHC

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867140448

UNIVERS REVS LG HUM STEM INS CS
ARTHREX, INC.
AR-9501LHC
In Commercial Distribution

  • 00888867140448 ()
AR-9501LHC

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867140370

UNIVERS REVERS SCREW CADDY
ARTHREX, INC.
AR-9501GC-SC
In Commercial Distribution

  • 00888867140370 ()
AR-9501GC-SC

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867140363

UNIVERS REVERS GLENOID INSTRUMENT CASE
ARTHREX, INC.
AR-9501GC
In Commercial Distribution

  • 00888867140363 ()
AR-9501GC

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867139640

INTRAMEDULLARY HUMERAL CUTTING GUIDE
ARTHREX, INC.
AR-9401-14
In Commercial Distribution

  • 00888867139640 ()
AR-9401-14

  • Surgical depth gauge, reusable

Arthrex® - 00888867139602

INSTR CS,ECLIPSE ARTHROPLASTY SYS
ARTHREX, INC.
AR-9400C4
In Commercial Distribution

  • 00888867139602 ()
AR-9400C4

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867138636

C-RING TARGET - 25MM
ARTHREX, INC.
AR-9261-06
In Commercial Distribution

  • 00888867138636 ()
AR-9261-06

  • Joint prosthesis implantation kit, reusable

Arthrex® - 00888867138629

C-RING TARGET - 20MM
ARTHREX, INC.
AR-9261-05
In Commercial Distribution

  • 00888867138629 ()
AR-9261-05

  • Joint prosthesis implantation kit, reusable

Arthrex® - 00888867138612

C-RING TARGET - 15MM
ARTHREX, INC.
AR-9261-04
In Commercial Distribution

  • 00888867138612 ()
AR-9261-04

  • Joint prosthesis implantation kit, reusable

Arthrex® - 00888867138605

C-RING
ARTHREX, INC.
AR-9261-03
In Commercial Distribution

  • 00888867138605 ()
AR-9261-03

  • Joint prosthesis implantation kit, reusable

Arthrex® - 00888867138599

CUTTING GUIDE
ARTHREX, INC.
AR-9261-02
In Commercial Distribution

  • 00888867138599 ()
AR-9261-02

  • Joint prosthesis implantation kit, reusable

Arthrex® - 00888867138575

SHOULDER ARTHROPLASTY RETRACTOR SET
ARTHREX, INC.
AR-9260S-53
In Commercial Distribution

  • 00888867138575 ()
AR-9260S-53

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Arthrex® - 00888867138544

DARRACH ELEVTR,10"LX3/8"W, BLNT W/SERR
ARTHREX, INC.
AR-9260-51
In Commercial Distribution

  • 00888867138544 ()
AR-9260-51

  • Bone lever/elevator, reusable

Arthrex® - 00888867138537

BROWNE DELTOID RETRACTOR
ARTHREX, INC.
AR-9260-50
In Commercial Distribution

  • 00888867138537 ()
AR-9260-50

  • Hand-held surgical retractor, reusable

Arthrex® - 00888867138520

COBRA RETRACTOR, 11 1/2" BLUNT, SERRATED
ARTHREX, INC.
AR-9260-49
In Commercial Distribution

  • 00888867138520 ()
AR-9260-49

  • Hand-held surgical retractor, reusable

Arthrex® - 00888867138513

HOHMANN RETRTR,9.75" LGX 19MM WD BLADE
ARTHREX, INC.
AR-9260-48
In Commercial Distribution

  • 00888867138513 ()
AR-9260-48

  • Hand-held surgical retractor, reusable

Arthrex® - 00888867138483

KOLBEL RETRACTOR, 8" LONG, RING HANDLE
ARTHREX, INC.
AR-9260-45
In Commercial Distribution

  • 00888867138483 ()
AR-9260-45

  • Hand-held surgical retractor, reusable

Arthrex® - 00888867138476

GELPI RETRACTOR, 7.25", SHARP
ARTHREX, INC.
AR-9260-44
In Commercial Distribution

  • 00888867138476 ()
AR-9260-44

  • Hand-held surgical retractor, reusable

Arthrex® - 00888867138469

GELPI RETRACTOR, 7.25", BLUNT TIP
ARTHREX, INC.
AR-9260-43
In Commercial Distribution

  • 00888867138469 ()
AR-9260-43

  • Hand-held surgical retractor, reusable

Arthrex® - 00888867138452

RICHARDSON RETRTR,3/4"WDX 2" DPX 9.5" LG
ARTHREX, INC.
AR-9260-42
In Commercial Distribution

  • 00888867138452 ()
AR-9260-42

  • Hand-held surgical retractor, reusable

Arthrex® - 00888867138445

RICHARDSON RETRTR,1.5 WDX 1.5 DPX 9.5 LG
ARTHREX, INC.
AR-9260-41
In Commercial Distribution

  • 00888867138445 ()
AR-9260-41

  • Hand-held surgical retractor, reusable

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

Arthrex® - 00888867138421

VOLKMANN RETRTR,8.5"LG 4 PRONG SEMI SHRP
ARTHREX, INC.
AR-9260-39
In Commercial Distribution

  • 00888867138421 ()
AR-9260-39

  • Hand-held surgical retractor, reusable

Arthrex® - 00888867138407

DARRACH ELEVTR,14" LGX 1" WD,BLNT W/SERR
ARTHREX, INC.
AR-9260-37
In Commercial Distribution

  • 00888867138407 ()
AR-9260-37

  • Bone lever/elevator, reusable

Integra® Miltex® - 10381780435228

Integra® Miltex® Adson Needle Holder 7-1/4", Fenestrated Jaws
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
8-70
In Commercial Distribution

  • H8348700 ()
  • 10381780435228 ()
8-70

  • 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
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