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

  • 00888867184176 ()
AR-6655

  • Manual orthopaedic bender, reusable
Univers Revers Humeral Case(2of2)
ARTHREX, INC.
AR-9501HC-2
In Commercial Distribution

  • 00888867184107 ()
AR-9501HC-2

  • Device sterilization/disinfection container, reusable
Univers Revers Humeral Case(1of2)
ARTHREX, INC.
AR-9501HC-1
In Commercial Distribution

  • 00888867184091 ()
AR-9501HC-1

  • Device sterilization/disinfection container, reusable
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
DRIVER, T8 HEXALOBE SELF RETAINING
ARTHREX, INC.
AR-8916-27
In Commercial Distribution

  • 00888867177628 ()
AR-8916-27

  • Orthopaedic inorganic implant inserter/extractor, reusable
Suture Cutter, Top Release
ARTHREX, INC.
SP-12250-1
In Commercial Distribution

  • 00888867175136 ()
SP-12250-1

  • General-purpose surgical scissors, reusable
Hamstring Donor Site Delivery Tube
ARTHREX, INC.
AR-1280-1
In Commercial Distribution

  • 00888867153172 ()
AR-1280-1

  • Orthopaedic graft inserter, reusable
Univers Revers Reduction Helper
ARTHREX, INC.
AR-9545
In Commercial Distribution

  • 00888867141636 ()
AR-9545

  • Surgical depth gauge, reusable
UNIVERS REVS REVISION SSTEM INSTR CS
ARTHREX, INC.
AR-9501RHC
In Commercial Distribution

  • 00888867140462 ()
AR-9501RHC

  • Device sterilization/disinfection container, reusable
UNIVERS REVS LG HUM STEM INS CS
ARTHREX, INC.
AR-9501LHC
In Commercial Distribution

  • 00888867140448 ()
AR-9501LHC

  • Device sterilization/disinfection container, reusable
UNIVERS REVERS SCREW CADDY
ARTHREX, INC.
AR-9501GC-SC
In Commercial Distribution

  • 00888867140370 ()
AR-9501GC-SC

  • Device sterilization/disinfection container, reusable
UNIVERS REVERS GLENOID INSTRUMENT CASE
ARTHREX, INC.
AR-9501GC
In Commercial Distribution

  • 00888867140363 ()
AR-9501GC

  • Device sterilization/disinfection container, reusable
INTRAMEDULLARY HUMERAL CUTTING GUIDE
ARTHREX, INC.
AR-9401-14
In Commercial Distribution

  • 00888867139640 ()
AR-9401-14

  • Surgical depth gauge, reusable
INSTR CS,ECLIPSE ARTHROPLASTY SYS
ARTHREX, INC.
AR-9400C4
In Commercial Distribution

  • 00888867139602 ()
AR-9400C4

  • Device sterilization/disinfection container, reusable
C-RING TARGET - 25MM
ARTHREX, INC.
AR-9261-06
In Commercial Distribution

  • 00888867138636 ()
AR-9261-06

  • Joint prosthesis implantation kit, reusable
C-RING TARGET - 20MM
ARTHREX, INC.
AR-9261-05
In Commercial Distribution

  • 00888867138629 ()
AR-9261-05

  • Joint prosthesis implantation kit, reusable
C-RING TARGET - 15MM
ARTHREX, INC.
AR-9261-04
In Commercial Distribution

  • 00888867138612 ()
AR-9261-04

  • Joint prosthesis implantation kit, reusable
C-RING
ARTHREX, INC.
AR-9261-03
In Commercial Distribution

  • 00888867138605 ()
AR-9261-03

  • Joint prosthesis implantation kit, reusable
CUTTING GUIDE
ARTHREX, INC.
AR-9261-02
In Commercial Distribution

  • 00888867138599 ()
AR-9261-02

  • Joint prosthesis implantation kit, reusable
SHOULDER ARTHROPLASTY RETRACTOR SET
ARTHREX, INC.
AR-9260S-53
In Commercial Distribution

  • 00888867138575 ()
AR-9260S-53

  • Orthopaedic surgical procedure kit, non-medicated, reusable
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
BROWNE DELTOID RETRACTOR
ARTHREX, INC.
AR-9260-50
In Commercial Distribution

  • 00888867138537 ()
AR-9260-50

  • Hand-held surgical retractor, reusable
COBRA RETRACTOR, 11 1/2" BLUNT, SERRATED
ARTHREX, INC.
AR-9260-49
In Commercial Distribution

  • 00888867138520 ()
AR-9260-49

  • Hand-held surgical retractor, reusable
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
KOLBEL RETRACTOR, 8" LONG, RING HANDLE
ARTHREX, INC.
AR-9260-45
In Commercial Distribution

  • 00888867138483 ()
AR-9260-45

  • Hand-held surgical retractor, reusable
GELPI RETRACTOR, 7.25", SHARP
ARTHREX, INC.
AR-9260-44
In Commercial Distribution

  • 00888867138476 ()
AR-9260-44

  • Hand-held surgical retractor, reusable
GELPI RETRACTOR, 7.25", BLUNT TIP
ARTHREX, INC.
AR-9260-43
In Commercial Distribution

  • 00888867138469 ()
AR-9260-43

  • Hand-held surgical retractor, reusable
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
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
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
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
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® 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
Depth Device, f/ 1.35mm Wire Sleeve
ARTHREX, INC.
AR-8963-09
In Commercial Distribution

  • 00888867230828 ()
AR-8963-09

  • Surgical depth gauge, reusable
2.7mm Threaded Drill Guide, 10-60mm
ARTHREX, INC.
AR-8963-08
In Commercial Distribution

  • 00888867230811 ()
AR-8963-08

  • Surgical drill guide, reusable
Wire Sleeve Insert, 1.35mm
ARTHREX, INC.
AR-8963-03
In Commercial Distribution

  • 00888867230798 ()
AR-8963-03

  • Surgical drill guide, reusable
2.7MM STRAIGHT PLATE CADDY & LID
ARTHREX, INC.
AR-8963C-02
In Commercial Distribution

  • 00888867230767 ()
AR-8963C-02

  • Device sterilization/disinfection container, reusable
DISTAL TIBIA PLATING CASE
ARTHREX, INC.
AR-8963C
In Commercial Distribution

  • 00888867230743 ()
AR-8963C

  • Device sterilization/disinfection container, reusable
Hamstring Donor Site Delivery Tube
ARTHREX, INC.
AR-1280
In Commercial Distribution

  • 10888867229386 ()
  • 00888867229389 ()
AR-1280

  • Orthopaedic graft inserter, reusable
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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