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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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End Cap, Screws
ARTHREX, INC.
AR-8964-22
In Commercial Distribution

  • 00888867241404 ()
  • M150AR8964220 ()
  • 10888867241401 ()
AR-8964-22

  • External orthopaedic fixation system, single-use
Ø1.35MM GUIDE WIRE, DUAL TROCAR
ARTHREX, INC.
AR-5050-01
In Commercial Distribution

  • 00888867233850 ()
  • 10888867233857 ()
AR-5050-01

  • Fluted surgical drill bit, reusable
Guide Wire, 1.35mm, Trocar Tip
ARTHREX, INC.
AR-8963-04
In Commercial Distribution

  • 00888867230804 ()
  • 10888867230801 ()
AR-8963-04

  • Fluted surgical drill bit, single-use
Guide Wire, Ø.090 x 4"
ARTHREX, INC.
AR-7011
In Commercial Distribution

  • 00888867207219 ()
  • 10888867207216 ()
AR-7011

  • Orthopaedic intraoperative positioning pin, single-use
GUIDE PIN, 2.4MM, SLOTTED
ARTHREX, INC.
SP-1250
In Commercial Distribution

  • 00888867205987 ()
  • 10888867205984 ()
SP-1250

  • Orthopaedic bone pin, non-bioabsorbable
iBALANCE TKA, TROCAR PIN SMOOTH
ARTHREX, INC.
AR-613-50
In Commercial Distribution

  • 00888867116542 ()
  • 10888867116549 ()
AR-613-50

  • Orthopaedic fixation implant alignment tool
GUIDE PIN W/SUTURE EYE 2.4MM
ARTHREX, INC.
AR-1297L
In Commercial Distribution

  • 10888867088082 ()
  • 00888867088085 ()
AR-1297L

  • Fluted surgical drill bit, single-use
GUIDE PIN W/SUTURE EYE 1.7MM
ARTHREX, INC.
AR-1297
In Commercial Distribution

  • 10888867088075 ()
  • 00888867088078 ()
AR-1297

  • Orthopaedic intraoperative positioning pin, single-use
GUIDE WIRE W/TROCAR TIP, THREADED, 12"
ARTHREX, INC.
AR-8967KT-12
In Commercial Distribution

  • 00888867056770 ()
  • 10888867056777 ()
AR-8967KT-12

  • Fluted surgical drill bit, single-use
GUIDE WIRE W/TROCAR TIP, THREADED, 8"
ARTHREX, INC.
AR-8967KT
In Commercial Distribution

  • 00888867056763 ()
  • 10888867056760 ()
AR-8967KT

  • Fluted surgical drill bit, single-use
G-WIRE W/TRCR TIP,NON-THRDED,12"
ARTHREX, INC.
AR-8967K-12
In Commercial Distribution

  • 00888867056756 ()
  • 10888867056753 ()
AR-8967K-12

  • Fluted surgical drill bit, single-use
G-WIRE W/TRCR TIP .094"X8" (2.4X 200MM)
ARTHREX, INC.
AR-8967K
In Commercial Distribution

  • 00888867056749 ()
  • 10888867056746 ()
AR-8967K

  • Fluted surgical drill bit, single-use
GDWIRE W/TRCR TIP .078"X8" (2MMX 200MM)
ARTHREX, INC.
AR-8956K-01
In Commercial Distribution

  • 10888867055800 ()
  • 00888867055803 ()
AR-8956K-01

  • Fluted surgical drill bit, single-use
SCHANZ PIN, 5.0MM
ARTHREX, INC.
AR-8954-01
In Commercial Distribution

  • 00888867055230 ()
  • 10888867055237 ()
AR-8954-01

  • Orthopaedic bone pin, non-bioabsorbable
G-WIRE W/DBL TRCR TIP,.045"X6.84"
ARTHREX, INC.
AR-8950-06
In Commercial Distribution

  • 00888867054400 ()
  • 10888867054407 ()
AR-8950-06

  • Fluted surgical drill bit, single-use
THREADED GUIDE WIRE W/ TROCAR TIP, .078"
ARTHREX, INC.
AR-8945KT
In Commercial Distribution

  • 10888867054094 ()
  • 00888867054097 ()
AR-8945KT

  • Orthopaedic bone pin, non-bioabsorbable
G-WIRE W/TRCR TIP .078"X5.91"(2MMX150MM)
ARTHREX, INC.
AR-8945K
In Commercial Distribution

  • 00888867054080 ()
  • 10888867054087 ()
AR-8945K

  • Orthopaedic intraoperative positioning pin, single-use
THRDED G-WIRE W/TRCR TIP,Ø 1.35MM
ARTHREX, INC.
AR-8943-38
In Commercial Distribution

  • 00888867052451 ()
  • 10888867052458 ()
AR-8943-38

  • Orthopaedic intraoperative positioning pin, single-use
GUIDE WIRE, TROCAR TIP, 1.35 MM
ARTHREX, INC.
AR-8943-01
In Commercial Distribution

  • 00888867052116 ()
  • 10888867052113 ()
AR-8943-01

  • Suturing unit, single-use
THRDED GDWIRE W/TRCR TIP,.045"X3.75"
ARTHREX, INC.
AR-8933KT
In Commercial Distribution

  • 00888867049970 ()
  • 10888867049977 ()
AR-8933KT

  • Orthopaedic intraoperative positioning pin, single-use
GUIDE WIRE, .045" X 5.91"
ARTHREX, INC.
AR-8933K
In Commercial Distribution

  • 00888867049956 ()
  • 10888867049953 ()
AR-8933K

  • Orthopaedic intraoperative positioning pin, single-use
GDWIRE,T-ROPE SYNDESMOSIS REPR KIT
ARTHREX, INC.
AR-8920P
In Commercial Distribution

  • 00888867049024 ()
  • 10888867049021 ()
AR-8920P

  • Fluted surgical drill bit, single-use
GDWIRE,0.86MM W/LASER LINE,THRDED,SS
ARTHREX, INC.
AR-8737-22
In Commercial Distribution

  • 00888867046177 ()
  • 10888867046174 ()
AR-8737-22

  • Fluted surgical drill bit, single-use
GUIDEWIRE, 0.86MM W/ LASER LINE, SS
ARTHREX, INC.
AR-8737-21
In Commercial Distribution

  • 00888867046160 ()
  • 10888867046167 ()
AR-8737-21

  • Suturing unit, single-use
THD GDWIRE W TRCR TIP,.045" W/LASER LINE
ARTHREX, INC.
AR-8737-05
In Commercial Distribution

  • 00888867046009 ()
  • 10888867046006 ()
AR-8737-05

  • Suturing unit, single-use
THRDED G-WIRE W/TRCR TIP,Ø 1.35MM
ARTHREX, INC.
AR-8737-02
In Commercial Distribution

  • 00888867045972 ()
  • 10888867045979 ()
AR-8737-02

  • Suturing unit, single-use
GUIDE WIRE, 1MM (.039")
ARTHREX, INC.
AR-8708K
In Commercial Distribution

  • 00888867044821 ()
  • 10888867044828 ()
AR-8708K

  • Suturing unit, single-use
iBALANCE TKA, THREADED PIN, HEADED
ARTHREX, INC.
AR-603-72
In Commercial Distribution

  • 00888867038707 ()
  • 10888867038704 ()
AR-603-72

  • Suturing unit, single-use
GUIDEWIRE FOR BIO- COMPRESSION SCREW
ARTHREX, INC.
AR-5025K
In Commercial Distribution

  • 00888867034839 ()
  • 10888867034836 ()
AR-5025K

  • Orthopaedic intraoperative positioning pin, single-use
PROSTOP PLUS GUIDE WIRE, .054" DIAMETER
ARTHREX, INC.
AR-4206
In Commercial Distribution

  • 00888867033467 ()
  • 10888867033464 ()
AR-4206

  • Fluted surgical drill bit, single-use
GUIDE WIRE, 0.078" DIA
ARTHREX, INC.
AR-4202
In Commercial Distribution

  • 00888867033320 ()
  • 10888867033327 ()
AR-4202

  • Orthopaedic intraoperative positioning pin, single-use
ACC; Charger 4-Bay Set; 4-Bay Charger w/ USB, 45W PSU For MaxLite Elite™ GEN 1
Modern Surgical Instruments LLC
MAX9003
In Commercial Distribution

  • 00850017626362 ()


  • General-purpose light source
ACC; Charger 4-Bay Console; 4-Bay Desktop Charger (No USB) For MaxLite Elite™ GEN 1
Modern Surgical Instruments LLC
MAX9002
In Commercial Distribution

  • 00850017626355 ()


  • General-purpose light source
MaxLite Elite Headband
Modern Surgical Instruments LLC
MAX9000HB
In Commercial Distribution

  • 00850017626348 ()


  • Head-worn lamp
MaxLite Elite Demo Kit
Modern Surgical Instruments LLC
MAX9000DK
In Commercial Distribution

  • 00850017626331 ()


  • Head-worn lamp
MAXLITE ELITE Headlight / Bezel, x 6 LiPO Batteries, 1 USB wall charger, 4 Bay Battery Charger, 1 Carrying Case
Modern Surgical Instruments LLC
MAX9000
In Commercial Distribution

  • 00850017626324 ()


  • General-purpose light source
5mm Nerve Hook
Modern Surgical Instruments LLC
44-069-20
In Commercial Distribution

  • 00850017626287 ()


  • Soft-tissue surgical hook, reusable
SL Narrow Muscle Blade 50mm Short Teeth Anodised Dark Viloet
Modern Surgical Instruments LLC
18-5550
In Commercial Distribution

  • 00850017626126 ()


  • Surgical retractor/retraction system blade, reusable
SL Tissue Blade 50mm Anodised Dark Violet
Modern Surgical Instruments LLC
18-5150
In Commercial Distribution

  • 00850017626119 ()


  • Surgical retractor/retraction system blade, reusable
4" L x 2.75" W BALL & SOCKET INSTRUMENT STRINGER
INTERNATIONAL SURGICAL PRODUCTS INC
STBS-4
In Commercial Distribution

  • 00850017474994 ()


  • Sterilization stringer
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