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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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Hand Tool #15 Driver for 3.5mm one piece Implant (CB)
Suncoast Dental, Inc
Hand Tool / HT.15
In Commercial Distribution

  • 00083208150043 ()

  • Hand tool #15 Driver for 3.5mm one piece Implants (CB)
HT.15

  • Dental implant system
Hand Tool #14 Driver for 3.0mm and 3.5mm one piece ball post Implant (SB) and 3.5-4.0mm two-piece small ball abutment.
Suncoast Dental, Inc
Hand Tool / HT.14
In Commercial Distribution

  • 00083208140044 ()

  • Hand Tool #14 Driver for 3.0mm and 3.5mm one piece ball post Implant (SB) and 3.5-4.0mm two-piece small ball abutment.
HT.14

  • Dental implant system
Tatum Mallet for use with Osteotomes for preparation of osteotomy for Implant placement
Suncoast Dental, Inc
Mallet T
In Commercial Distribution

  • 00083208130007 ()
Mallet T

  • Surgical mallet
Hand Tool #12 Driver for 3.0mm one piece Implant (CB)
Suncoast Dental, Inc
Hand Tool / HT.12
In Commercial Distribution

  • 00083208120046 ()

  • Hand tool #12 Driver for 3.0mm one piece Implants (CB)
HT.12

  • Dental implant system
Hand Tool #11 Hex driver 1mm with handle
Suncoast Dental, Inc
Hand Tool / HT.11
In Commercial Distribution

  • 00083208110047 ()

  • Hand Tool #11 hex driver 1mm with handle to fit Unipost abutments and unipost healing screws
HT.11

  • Dental implant system
MODIFIED INSTRUMENT INSERTION BLADE 12-14mm
DEPUY SPINE, LLC
698344571
In Commercial Distribution

  • 10705034569277 ()
698344571

  • Orthopaedic inorganic implant inserter/extractor, reusable
MODIFIED INSTRUMENT DRIVER X20
DEPUY SPINE, LLC
698344568
In Commercial Distribution

  • 10705034569239 ()
698344568

  • Orthopaedic implant impactor, reusable
MODIFIED INSTRUMENT NUT DRIVER
DEPUY SPINE, LLC
698344604
In Commercial Distribution

  • 10705034568980 ()
698344604

  • Orthopaedic implant driver
MODIFIED INSTRUMENT DRIVER X25
DEPUY SPINE, LLC
698344600
In Commercial Distribution

  • 10705034568942 ()
698344600

  • Surgical screwdriver, reusable
Initial Driver, T25
NEXXT SPINE, LLC
I10-04-25
In Commercial Distribution

  • 00889929017609 ()


  • General internal orthopaedic fixation system implantation kit
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