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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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Screwdriver, Split Tip Size 20
K2M, INC.
PRO-1313-01
In Commercial Distribution

  • 10888857560444 ()
PRO-1313-01

  • Surgical screwdriver, reusable
Locking Screw Inserter
K2M, INC.
PRO-1316
In Commercial Distribution

  • 10888857560413 ()
PRO-1316

  • Orthopaedic implant driver
Universal Driver Size 20
K2M, INC.
PRO-1313-02
In Commercial Distribution

  • 10888857560062 ()
PRO-1313-02

  • Surgical screwdriver, reusable
Screw Driver w/ Thread
K2M, INC.
PRO-1156
In Commercial Distribution

  • 10888857548602 ()
PRO-1156

  • Orthopaedic prosthesis implantation positioning instrument, reusable
PAUL BANDITT, NYLON REPLACEMENT TIPS FOR " NYLON" MALLET, Per pair
Terlain Enterprises, Inc.
PARTNYLON
In Commercial Distribution

  • D955PARTNYLON1 ()


  • Surgical mallet
PAUL BANDITT, REPLACEMENT TIPS FOR " MEAD" MALLET, Per pair
Terlain Enterprises, Inc.
PARTMEAD
In Commercial Distribution

  • D955PARTMEAD1 ()


  • Surgical mallet
PAUL BANDITT NYLON, NYLON TIPPED MALLET, 180GM HOLLOW HANDLE, 18CM
Terlain Enterprises, Inc.
MALNYLON
In Commercial Distribution

  • D955MALNYLON1 ()


  • Surgical mallet
PAUL BANDITT MEAD MALLET, 19CM, 320GM
Terlain Enterprises, Inc.
MALMEAD
In Commercial Distribution

  • D955MALMEAD1 ()


  • Surgical mallet
PAUL BANDITT GARDNER MALLET, 14.5CM
Terlain Enterprises, Inc.
MALGARDNER
In Commercial Distribution

  • D955MALGARDNER1 ()


  • Surgical mallet
SPECIAL CASSETTE FOR X EASY BONE EXPANDER / SINUS LIFT / ROOT EXTRACTION WITH UNIVERSAL LATCHET DRIVER SET OF 7
Power Dental U.S.A. Inc.
7830-7
In Commercial Distribution

  • D94378307 ()
7830-7

  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
  • Dressing/utility forceps, scissors-like, reusable
X UNVERSAL LATCHET DRIVER (FOR LOW SPEED HANDPIECE BUR)
Power Dental U.S.A. Inc.
7830-6
In Commercial Distribution

  • D943783060 ()
7830-6

  • Dressing/utility forceps, scissors-like, reusable
  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
IMPLANT HEX DRIVER 2.5mm
Power Dental U.S.A. Inc.
7830-3
In Commercial Distribution

  • D94378303 ()
7830-3

  • Dressing/utility forceps, scissors-like, reusable
  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
X EASY BONE EXPANDER / SINUS LIFT / ROOT EXTRACTION WITH UNIVERSAL LATCHET DRIVER, SET OF 7
Power Dental U.S.A. Inc.
7830
In Commercial Distribution

  • D9437830 ()
7830

  • Dressing/utility forceps, scissors-like, reusable
  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
TORQUE DRIVER
Power Dental U.S.A. Inc.
N1984N
In Commercial Distribution

  • D943N1984N00 ()
N1984N

  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
SAS EX0113053 DRIVER
MEDTRONIC SOFAMOR DANEK, INC.
EX0113053
In Commercial Distribution

  • 00643169330856 ()


  • Orthopaedic implant driver
CONTRAANGLE DRIVER FOR 4,3 & 5,0 IMPLANT LONG
ODONTIT S.A.
ACTL-43
In Commercial Distribution

  • D914ACTL430 ()
ACTL-43

  • Screw endosteal dental implant, two-piece
CONTRAANGLE DRIVER FOR 3,5 IMPLANT LONG
ODONTIT S.A.
ACTL-35
In Commercial Distribution

  • D914ACTL350 ()
ACTL-35

  • Screw endosteal dental implant, two-piece
CONTRAANGLE DRIVER FOR 3,0 IMPLANT
ODONTIT S.A.
ACTL
In Commercial Distribution

  • D914ACTL0 ()
ACTL

  • Screw endosteal dental implant, two-piece
CONTRAANGLE DRIVER FOR 4,3 & 5,0 IMPLANT SHORT
ODONTIT S.A.
ACTC-43
In Commercial Distribution

  • D914ACTC430 ()
ACTC-43

  • Screw endosteal dental implant, two-piece
CONTRAANGLE DRIVER FOR 3,5 IMPLANT SHORT
ODONTIT S.A.
ACTC-35
In Commercial Distribution

  • D914ACTC350 ()
ACTC-35

  • Screw endosteal dental implant, two-piece
RATCHET WRENCH DRIVER FOR 4,3 & 5,0 IMPLANT LONG
ODONTIT S.A.
ACML-43
In Commercial Distribution

  • D914ACML430 ()
ACML43

  • Screw endosteal dental implant, two-piece
RATCHET WRENCH DRIVER FOR 3,5 IMPLANT LONG
ODONTIT S.A.
ACML-35
In Commercial Distribution

  • D914ACML350 ()
ACML-35

  • Screw endosteal dental implant, two-piece
RATCHET WRENCH DRIVER FOR 3,0 IMPLANT
ODONTIT S.A.
ACML
In Commercial Distribution

  • D914ACML0 ()
ACML

  • Screw endosteal dental implant, two-piece
RATCHET WRENCH DRIVER FOR 4,3 & 5,0 IMPLANT SHORT
ODONTIT S.A.
ACMC-43
In Commercial Distribution

  • D914ACMC430 ()
ACMC-43

  • Screw endosteal dental implant, two-piece
RATCHET WRENCH DRIVER FOR 3,5 IMPLANT SHORT
ODONTIT S.A.
ACMC-35
In Commercial Distribution

  • D914ACMC350 ()
ACMC-35

  • Screw endosteal dental implant, two-piece
ALIF Screwdriver XL
AXIS SPINE TECHNOLOGIES LTD
A6200350
In Commercial Distribution

  • 05056619800680 ()
A6200350

  • Surgical screwdriver, reusable
Hex Srew Driver 0.48 long
ODONTIT S.A.
THDL48
In Commercial Distribution

  • D914THDL480 ()
THDL48

  • Screw endosteal dental implant, two-piece
Hex Srew Driver 0.48 short
ODONTIT S.A.
THDC48
In Commercial Distribution

  • D914THDC480 ()
THDC48

  • Screw endosteal dental implant, two-piece
SmartGrip driver short
ODONTIT S.A.
SGDS
In Commercial Distribution

  • D914SGDS0 ()
SGDS

  • Screw endosteal dental implant, two-piece
SmartGrip driver long
ODONTIT S.A.
SGDL
In Commercial Distribution

  • D914SGDL0 ()
SGDL

  • Screw endosteal dental implant, two-piece
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