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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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n/a - 00643169783652

SCREWDRIVER EX0416052 U JOINT T25
MEDTRONIC SOFAMOR DANEK, INC.
EX0416052
In Commercial Distribution

  • 00643169783652 ()


  • Surgical screwdriver, reusable

N/A - 00643169789326

DRIVER X1215009 TAMPONADE
MEDTRONIC SOFAMOR DANEK, INC.
X1215009
In Commercial Distribution

  • 00643169789326 ()


  • Surgical screwdriver, reusable

Medtronic Reusable Instruments - 00643169785984

REMOVAL BIT X0815014 T27 WITH OBTURATOR
MEDTRONIC SOFAMOR DANEK, INC.
X0815014
In Commercial Distribution

  • 00643169785984 ()


  • Surgical screwdriver, reusable

Medtronic Reusable Instruments - 00643169785960

DRIVER X0714017 6.35MM PROVISIONAL
MEDTRONIC SOFAMOR DANEK, INC.
X0714017
In Commercial Distribution

  • 00643169785960 ()


  • Orthopaedic implant driver

Medtronic Reusable Instruments - 00643169785939

SCREWDRIVER X0714014 FIXED AXIAL
MEDTRONIC SOFAMOR DANEK, INC.
X0714014
In Commercial Distribution

  • 00643169785939 ()


  • Orthopaedic implant driver

Medtronic Reusable Instruments - 00643169785922

SCREWDRIVER X0714013 MULTI AXIAL
MEDTRONIC SOFAMOR DANEK, INC.
X0714013
In Commercial Distribution

  • 00643169785922 ()


  • Orthopaedic implant driver

n/a - 00643169785687

DRIVER 6550031 5.5/6.0 SV NUT DRIVER
MEDTRONIC SOFAMOR DANEK, INC.
6550031
In Commercial Distribution

  • 00643169785687 ()


  • Surgical screwdriver, reusable

HawkOne™ - 00643169777644

ATHERECTOMY H1-14550 CUTTER DRIVER V03
Covidien LP
H1-14550
In Commercial Distribution

  • 00643169777644 ()


  • Mechanical atherectomy system catheter, peripheral

N/A - 00643169957329

SCREWDRIVER EX0117067 SHORTEN STRGHT HEX
MEDTRONIC SOFAMOR DANEK, INC.
EX0117067
In Commercial Distribution

  • 00643169957329 ()


  • Surgical screwdriver, reusable

N/A - 00643169953284

DRIVER EX0117005 SET SCRW RETAINING 4.75
MEDTRONIC SOFAMOR DANEK, INC.
EX0117005
In Commercial Distribution

  • 00643169953284 ()


  • Orthopaedic implant driver

Medtronic Resuable Instruments - 00643169953086

DRIVER EX1016091 MAS SHORT 4.75MM
MEDTRONIC SOFAMOR DANEK, INC.
EX1016091
In Commercial Distribution

  • 00643169953086 ()


  • General internal orthopaedic fixation system implantation kit

Medtronic Resuable Instruments - 00643169953079

DRIVER EX1016090 MAS SHORT 5.5/6.0MM
MEDTRONIC SOFAMOR DANEK, INC.
EX1016090
In Commercial Distribution

  • 00643169953079 ()


  • General internal orthopaedic fixation system implantation kit

Medtronic Resuable Instruments - 00643169949997

INSTRUMENT EX1116116 SCREW REMOVAL T8T10
MEDTRONIC SOFAMOR DANEK, INC.
EX1116116
In Commercial Distribution

  • 00643169949997 ()


  • Surgical screwdriver, reusable

Medtronic Resuable Instruments - 00643169937987

DRIVER EX1116062 T-HANDLE
MEDTRONIC SOFAMOR DANEK, INC.
EX1116062
In Commercial Distribution

  • 00643169937987 ()


  • General internal orthopaedic fixation system implantation kit

Medtronic Resuable Instruments - 00643169800106

DRIVER EX0616012 SHORTEN T8-T10
MEDTRONIC SOFAMOR DANEK, INC.
EX0616012
In Commercial Distribution

  • 00643169800106 ()


  • Surgical screwdriver, reusable

N/A - 00643169800045

DRIVER X0416007 NUT 4.75 REDUCER
MEDTRONIC SOFAMOR DANEK, INC.
X0416007
In Commercial Distribution

  • 00643169800045 ()


  • Orthopaedic rod reducer

N/A - 00643169800038

REDUCER X0416006 4.75
MEDTRONIC SOFAMOR DANEK, INC.
X0416006
In Commercial Distribution

  • 00643169800038 ()


  • Surgical screwdriver, reusable

N/A - 00643169799950

SCREWDRIVER EX0616081 RETNG BONE 5.5/6.0
MEDTRONIC SOFAMOR DANEK, INC.
EX0616081
In Commercial Distribution

  • 00643169799950 ()


  • Surgical screwdriver, reusable

Medtronic Resuable Instruments - 00643169799660

AWL EX0616054 STRGHT FLEXIBLE-TROCAR TIP
MEDTRONIC SOFAMOR DANEK, INC.
EX0616054
In Commercial Distribution

  • 00643169799660 ()


  • Surgical screwdriver, reusable

N/A - 00643169799585

DRIVER EX0516002 SHORT PLATE HOLDING PIN
MEDTRONIC SOFAMOR DANEK, INC.
EX0516002
In Commercial Distribution

  • 00643169799585 ()


  • Orthopaedic implant driver

Materialise Mimics Enlight CMF - 05404028000953

Mimics Enlight CMF Reconstruction Planner
Materialise NV
Reconstruction Planner
In Commercial Distribution

  • 05404028000953 ()
Reconstruction Planner

  • CAD/CAM software

Materialise Mimics Enlight CMF - 05404028000946

Materialise Mimics Enlight CMF Orthognathic and Trauma Planner
Materialise NV
Orthognathic and Trauma Planner
In Commercial Distribution

  • 05404028000946 ()
Orthognathic and Trauma Planner

  • CAD/CAM software

Materialise Mimics Enlight CMF - 05404028000816

Mimics Enlight CMF Reconstruction Planner
Materialise NV
Reconstruction Planner
In Commercial Distribution

  • 05404028000816 ()
Reconstruction Planner

  • CAD/CAM software

Materialise Mimics Enlight CMF - 05404028000809

Mimics Enlight CMF Orthognathic Planner
Materialise NV
Orthognathic Planner
In Commercial Distribution

  • 05404028000809 ()
Orthognathic Planner

  • CAD/CAM software

neoClose 2 Anchor (Long Driver) US - 05391529640552

Laparoscopy wound closure system pack consists of: 05391529640439; neoClose Anchor (Long Driver) x 2 US; Model Number NCAALX2-U
NEOSURGICAL LIMITED
NCAALX2-U
In Commercial Distribution

  • 05391529640569 ()
  • 05391529640552 ()
  • 05391529640439 ()


  • Laparoscopic wound closure thread

Apex - 05391529588700

Flexible IM Reamer Shaft 650mm
ORTHOXEL DESIGNATED ACTIVITY COMPANY
INS-1156
In Commercial Distribution

  • 05391529588700 ()

  • 3.2 x 227.0mm
INS-1156

  • Medullary canal orthopaedic reamer shaft

Apex - 05391529588656

Flexible Hex Driver Ball Tip (5mm/8mm)
ORTHOXEL DESIGNATED ACTIVITY COMPANY
INS-1151
In Commercial Distribution

  • 05391529588656 ()

  • Ø7.92 x 195mm
INS-1151

  • Surgical screwdriver, reusable

Medtronic Resuable Instruments - 00643169694125

SCREWDRIVER EX0915017 SHAFT
MEDTRONIC SOFAMOR DANEK, INC.
EX0915017
In Commercial Distribution

  • 00643169694125 ()


  • Surgical screwdriver, reusable

NA - 00643169693838

DRIVER NAV2024K SOLERA 4.75 STANDARD MAS
MEDTRONIC SOFAMOR DANEK, INC.
NAV2024K
In Commercial Distribution

  • 00643169693838 ()

  • Outer Diameter: 4.75 Millimeter


  • Surgical screwdriver, reusable

CD HORIZON® Spinal System - 00643169693821

DRIVER NAV2024 SOLERA 4.75 STANDARD MAS
MEDTRONIC SOFAMOR DANEK, INC.
NAV2024
In Commercial Distribution

  • 00643169693821 ()


  • Surgical screwdriver, reusable

Medtronic Resuable Instruments - 00643169693715

PENFIELD X1015037 6.5 PUSH/PULL
MEDTRONIC SOFAMOR DANEK, INC.
X1015037
In Commercial Distribution

  • 00643169693715 ()


  • Surgical screwdriver, reusable

Medtronic Resuable Instruments - 00643169693678

ADAPTER X1015013 INLINE
MEDTRONIC SOFAMOR DANEK, INC.
X1015013
In Commercial Distribution

  • 00643169693678 ()


  • Orthopaedic implant driver

Medtronic Resuable Instruments - 00643169693661

DRIVER X1015012 INLINE
MEDTRONIC SOFAMOR DANEK, INC.
X1015012
In Commercial Distribution

  • 00643169693661 ()


  • Orthopaedic implant driver

Medtronic Resuable Instruments - 00643169652224

DRIVER EX0615015 BONESCREW T-25
MEDTRONIC SOFAMOR DANEK, INC.
EX0615015
In Commercial Distribution

  • 00643169652224 ()


  • Surgical screwdriver, reusable

N/A - 00643169641617

DRIVER 5482304 7/32 BREAKOFF DRIVER
MEDTRONIC SOFAMOR DANEK, INC.
5482304
In Commercial Distribution

  • 00643169641617 ()


  • Orthopaedic implant driver

Tall Separable Fastener 10-Pack, w/ Cementation Aid, Ditron - D990DDUSTSFCA10PK0

No Description
SMART DENTURE CONVERSIONS, LLC
DDUS-TSFCA10PK
In Commercial Distribution

  • D990DDUSTSFCA10PK0 ()


  • Surgical screwdriver, reusable
  • Dental prosthesis/implant abutment screw analog, single-use

Cementation Aid 10PK - D990CA10PK0

No Description
SMART DENTURE CONVERSIONS, LLC
CA10PK
In Commercial Distribution

  • D990CA10PK0 ()


  • Surgical screwdriver, reusable

Starter Kit, BioHorizons - D990BHHDSK0

No Description
SMART DENTURE CONVERSIONS, LLC
BHHD-SK
In Commercial Distribution

  • D990BHHDSK0 ()


  • Steel dental bur, reusable
  • Surgical screwdriver, reusable
  • Dental implant suprastructure, temporary, preformed, single-use
  • Dental implant abutment analog, laboratory
  • Dental prosthesis/implant abutment screw
  • Dental prosthesis/implant abutment screw analog, single-use

Premium Starter Kit, BioHorizons - D990BHHDPSK0

No Description
SMART DENTURE CONVERSIONS, LLC
BHHD-PSK
In Commercial Distribution

  • D990BHHDPSK0 ()


  • Steel dental bur, reusable
  • Surgical screwdriver, reusable
  • Dental implant suprastructure, temporary, preformed, single-use
  • Dental implant abutment analog, laboratory
  • Dental prosthesis/implant abutment screw
  • Dental prosthesis/implant abutment screw analog, single-use

Premium Starter Kit, TSV - D990ZVTSPSK0

No Description
SMART DENTURE CONVERSIONS, LLC
ZVTS-PSK
In Commercial Distribution

  • D990ZVTSPSK0 ()


  • Dental prosthesis/implant abutment screw analog, single-use
  • Dental implant suprastructure, temporary, preformed, single-use
  • Dental implant abutment analog, laboratory
  • Dental prosthesis/implant abutment screw
  • Steel dental bur, reusable
  • Surgical screwdriver, reusable

Retrieval Tool 1PK, ZimVie - D990ZVRT0

No Description
SMART DENTURE CONVERSIONS, LLC
ZV-RT
In Commercial Distribution

  • D990ZVRT0 ()


  • Surgical screwdriver, reusable

Low Torque Driver 1PK, ZimVie - D990ZVLTD0

No Description
SMART DENTURE CONVERSIONS, LLC
ZV-LTD
In Commercial Distribution

  • D990ZVLTD0 ()


  • Surgical screwdriver, reusable

Premium Starter Kit, Low Profile - D990ZVLPPSK0

No Description
SMART DENTURE CONVERSIONS, LLC
ZVLP-PSK
In Commercial Distribution

  • D990ZVLPPSK0 ()


  • Steel dental bur, reusable
  • Surgical screwdriver, reusable
  • Dental prosthesis/implant abutment screw
  • Dental implant abutment analog, laboratory
  • Dental implant suprastructure, temporary, preformed, single-use
  • Dental prosthesis/implant abutment screw analog, single-use

Starter Kit, Straumann - D990SKST0

No Description
SMART DENTURE CONVERSIONS, LLC
SK-ST
In Commercial Distribution

  • D990SKST0 ()


  • Steel dental bur, reusable
  • Surgical screwdriver, reusable
  • Dental implant suprastructure, temporary, preformed, single-use
  • Dental implant abutment analog, laboratory
  • Dental prosthesis/implant abutment screw
  • Dental prosthesis/implant abutment screw analog, single-use

Starter Kit, Unigrip - D990SK0

No Description
SMART DENTURE CONVERSIONS, LLC
SK
In Commercial Distribution

  • D990SK0 ()


  • Steel dental bur, reusable
  • Surgical screwdriver, reusable
  • Dental implant suprastructure, temporary, preformed, single-use
  • Dental implant abutment analog, laboratory
  • Dental prosthesis/implant abutment screw
  • Dental prosthesis/implant abutment screw analog, single-use

Starter Kit, SDC BioHorizons - D990SDBHSK0

No Description
SMART DENTURE CONVERSIONS, LLC
SDBH-SK
In Commercial Distribution

  • D990SDBHSK0 ()


  • Steel dental bur, reusable
  • Surgical screwdriver, reusable
  • Dental implant suprastructure, temporary, preformed, single-use
  • Dental implant abutment analog, laboratory
  • Dental prosthesis/implant abutment screw
  • Dental prosthesis/implant abutment screw analog, single-use

Premium Starter Kit, SDC BioHorizons - D990SDBHPSK0

No Description
SMART DENTURE CONVERSIONS, LLC
SDBH-PSK
In Commercial Distribution

  • D990SDBHPSK0 ()


  • Steel dental bur, reusable
  • Surgical screwdriver, reusable
  • Dental implant suprastructure, temporary, preformed, single-use
  • Dental implant abutment analog, laboratory
  • Dental prosthesis/implant abutment screw
  • Dental prosthesis/implant abutment screw analog, single-use

Leixir Starter Kit, Unigrip - D990LXDGSK0

No Description
SMART DENTURE CONVERSIONS, LLC
LXDG-SK
In Commercial Distribution

  • D990LXDGSK0 ()


  • Steel dental bur, reusable
  • Surgical screwdriver, reusable
  • Dental implant suprastructure, temporary, preformed, single-use
  • Dental implant abutment analog, laboratory
  • Dental prosthesis/implant abutment screw
  • Dental prosthesis/implant abutment screw analog, single-use

Leixir Premium Starter Kit, Unigrip - D990LXDGPSK0

No Description
SMART DENTURE CONVERSIONS, LLC
LXDG-PSK
In Commercial Distribution

  • D990LXDGPSK0 ()


  • Steel dental bur, reusable
  • Surgical screwdriver, reusable
  • Dental implant suprastructure, temporary, preformed, single-use
  • Dental implant abutment analog, laboratory
  • Dental prosthesis/implant abutment screw
  • Dental prosthesis/implant abutment screw analog, single-use

Torque Driver 1PK - D990LTD0

No Description
SMART DENTURE CONVERSIONS, LLC
LTD
In Commercial Distribution

  • D990LTD0 ()


  • Surgical screwdriver, reusable
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