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 #20 One piece Implant driver socket extension
Suncoast Dental, Inc
Hand Tool / HT.20
In Commercial Distribution

  • 00083208200045 ()

  • Hand Tool #20 One piece Implant driver socket extension
HT.20

  • Dental implant system
Hand Tool#19 Small ball post driver (non Hex)
Suncoast Dental, Inc
Hand Tool / HT.19
In Commercial Distribution

  • 00083208190049 ()

  • Hand Tool #19 Small Ball post driver (non-hex)
HT.19

  • Dental implant system
Hand Tool #18 Driver for 5.0mm one piece Implant (CB)
Suncoast Dental, Inc
Hand Tool / HT.18
In Commercial Distribution

  • 00083208180040 ()

  • Hand tool #18 Driver for 5.0mm one piece Implants (CB)
HT.18

  • Dental implant system
Hand Tool #17 Driver for 4.0 and 4.5mm one piece Implant (CB)
Suncoast Dental, Inc
Hand Tool / HT.17
In Commercial Distribution

  • 00083208170041 ()

  • Hand tool #17 Driver for 4.0-4.5mm one piece Implants (CB)
HT.17

  • Dental implant system
TEMA Elbow - Screwdriver Shaft for Axle T15
LIMACORPORATE SPA
9015.90.006
In Commercial Distribution

  • 08033390207935 ()
9015.90.006

  • Surgical screwdriver, reusable
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
Hand Tool #10 ADA hex driver 1mm
Suncoast Dental, Inc
Hand Tool / HT.10
In Commercial Distribution

  • 00083208100048 ()

  • Hand Tool #10 ADA hex driver 1mm to fit Unipost abutments and unipost healing screws
HT.10

  • Dental implant system
Hand Tool #9L ADA shank 4x2mm male driver to fit Integrity 6.0-8.0 Implants
Suncoast Dental, Inc
Hand Tool / HT.09L
In Commercial Distribution

  • 00083208090141 ()

  • Hand Tool #9L ADA shank 4x2mm male driver to fit Integrity 6.0-8.0 Implants
HT.09L

  • Dental implant system
Torque Wrench to 2.5mm Pentagon. Fits: Straight, Tapered and Integrity Implants 3.7-5.0
Suncoast Dental, Inc
HT.06U
In Commercial Distribution

  • 00083208060243 ()

  • 4.0mm Square Head
HT.06U

  • Surgical torque wrench adaptor
ITL - HTLT .050 driver (Long)
Suncoast Dental, Inc
HTLT .050 driver (Long)
In Commercial Distribution

  • 00083208025655 ()

  • .050
HTLT .050 driver (Long)

  • Surgical screwdriver, reusable
Hand Tool #1 Latch Grip Hand Driver 4mm
Suncoast Dental, Inc
Hand Tool / HT.01
In Commercial Distribution

  • 00083208010040 ()

  • Hand Tool #1 to fit latch grip hand tools HT.09/09L/Taps
HT.01

  • Dental implant system
Tatum One-Piece Implant Kit Box - #04-4870 - Autoclavable Box to hold all Drills, Drivers and ratchet for One-Piece Implant placement
Suncoast Dental, Inc
Tatum One-Piece Implant Kit Box
In Commercial Distribution

  • 00083208001000 ()
Tatum One-Piece Implant Kit Box

  • Instrument tray, reusable
EZ-Driver handle - Fits Tatum Drivers HT.09 & HT.09L, Adapter HT21 & all Taps.
Suncoast Dental, Inc
EZ-Driver Hex
In Commercial Distribution

  • 00083208000461 ()

  • 4.0mm Socket
EZ-Implant Driver Hex

  • Surgical screwdriver, reusable
EZ-Screw Driver, Hex Large
Suncoast Dental, Inc
EZSDL
Not in Commercial Distribution

  • 00083208000348 ()

  • 4.0mm Hex
EZSDL

  • Surgical screwdriver, reusable
Bone Fixation Screw Driver Tip for the EZ Screw Driver
Suncoast Dental, Inc
BFSDT Bone Fixation Screw Driver Tip
Not in Commercial Distribution

  • 00083208000249 ()

  • 2.4mm Square Head
BFSDT

  • Surgical screwdriver, reusable
Retentive Glenoid Pusher STD
LIMACORPORATE SPA
9013.79.547
In Commercial Distribution

  • 08033390143653 ()

  • STD
9013.79.547

  • Orthopaedic implant driver
Retentive Glenoid Pusher LARGE
LIMACORPORATE SPA
9013.79.548
In Commercial Distribution

  • 08033390143646 ()

  • LARGE
9013.79.548

  • Orthopaedic implant driver
Retentive Glenoid Pusher SMALL
LIMACORPORATE SPA
9013.79.546
In Commercial Distribution

  • 08033390143639 ()

  • SMALL
9013.79.546

  • Orthopaedic implant driver
2.5mm Screwdriver Shaft with AO Connection
LIMACORPORATE SPA
9095.11.451
In Commercial Distribution

  • 08033390139021 ()

  • 2.5mm
9095.11.451

  • Surgical screwdriver, reusable
2.5mm Hexagonal Screwdriver
LIMACORPORATE SPA
9095.11.401
In Commercial Distribution

  • 08033390138994 ()

  • 2.5mm
9095.11.401

  • Surgical screwdriver, reusable
Powered Pin Driver Single Hand Use
LIMACORPORATE SPA
9095.11.12S
In Commercial Distribution

  • 08033390137249 ()
9095.11.12S

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Powered Pin Driver
LIMACORPORATE SPA
9095.11.12A
In Commercial Distribution

  • 08033390133760 ()
9095.11.12A

  • Orthopaedic implant driver
Glenoid LOW Pusher
LIMACORPORATE SPA
Glenoid Pusher
In Commercial Distribution

  • 08033390121446 ()
9013.79.545

  • Orthopaedic implant driver
Glenoid Pusher
LIMACORPORATE SPA
Glenoid Pusher
In Commercial Distribution

  • 08033390121439 ()
9013.79.544

  • Orthopaedic implant driver
Quick Connection Driver - SMR Shoulder
LIMACORPORATE SPA
9013.79.215
In Commercial Distribution

  • 08033390119405 ()
9013.79.215

  • Orthopaedic reamer guide
DEPUY SPINE CABLE SYSTEM BY SONGER TORQUE SCREWDRIVER
DEPUY SPINE, LLC
7825120
In Commercial Distribution

  • 10705034007595 ()
7825120

  • Surgical screwdriver, reusable
AETI SYSTEM SPREADER SCREWDRIVER
DEPUY SPINE, LLC
6300160
Not in Commercial Distribution

  • 10705034007328 ()
6300160

  • Surgical screwdriver, reusable
SPINAL INSTRUMENT SPREADER BLOCK INSERTER
DEPUY SPINE, LLC
6000721
In Commercial Distribution

  • 10705034007243 ()
6000721

  • Orthopaedic inorganic implant inserter/extractor, reusable
SPINAL INSTRUMENT CAGE/GRAFT INSERTER
DEPUY SPINE, LLC
6000102
In Commercial Distribution

  • 10705034006987 ()
6000102

  • Orthopaedic inorganic implant inserter/extractor, reusable
SPINAL INSTRUMENT TRIAL/CAGE INSERTER
DEPUY SPINE, LLC
6000101
In Commercial Distribution

  • 10705034006970 ()
6000101

  • Orthopaedic inorganic implant inserter/extractor, reusable
KANEDA SR ANTERIOR SYSTEM STAPLE SCREWDRIVER
DEPUY SPINE, LLC
3004105
Not in Commercial Distribution

  • 10705034005201 ()
3004105

  • Surgical screwdriver, reusable
ISOLA SPINE SYSTEM OPEN HOOK DRIVER
DEPUY SPINE, LLC
2250251
In Commercial Distribution

  • 10705034005164 ()
2250251

  • Orthopaedic implant driver
ISOLA SPINE SYSTEM OPEN HOOK DRIVER 6.35mm
DEPUY SPINE, LLC
2050251
In Commercial Distribution

  • 10705034004839 ()
2050251

  • Orthopaedic implant driver
ISOLA SPINE SYSTEM OPEN HOOK DRIVER 4.75mm
DEPUY SPINE, LLC
2050241
In Commercial Distribution

  • 10705034004822 ()
2050241

  • Orthopaedic implant driver
KANEDA SR ANTERIOR SYSTEM CLOSED SCREW TIP 4.75mm / 6.35mm
Medos International Sàrl
2040258
In Commercial Distribution

  • 10705034004693 ()
2040258

  • Orthopaedic fixation implant alignment tool
KANEDA SR ANTERIOR SYSTEM OPEN SCREW TIP 6.35mm
DEPUY SPINE, LLC
2040257
In Commercial Distribution

  • 10705034004686 ()
2040257

  • Orthopaedic fixation implant alignment tool
KANEDA SR ANTERIOR SYSTEM UNIVERSAL DRIVER
Medos International Sàrl
2040253
In Commercial Distribution

  • 10705034004662 ()
2040253

  • Orthopaedic implant driver
VSP SPINE SYSTEM BONE PLATE MANIPULATOR
DEPUY SPINE, LLC
2025106
Not in Commercial Distribution

  • 10705034003849 ()
2025106

  • Surgical implant handling forceps
SLIM-LOC ANTERIOR CERVICAL PLATE SYSTEM Drill for 14mm Screw
Cerenovus, Inc.
465174
Not in Commercial Distribution

  • 10705034003191 ()
465174

  • Orthopaedic implant driver
SLIM-LOC ANTERIOR CERVICAL PLATE SYSTEM Drill for 12mm Screw
Cerenovus, Inc.
465172
Not in Commercial Distribution

  • 10705034003184 ()
465172

  • Orthopaedic implant driver
ISOLA SPINE SYSTEM CABLE/WIRE SCREWDRIVER
DEPUY SPINE, LLC
205197
Not in Commercial Distribution

  • 10705034001708 ()
205197

  • Surgical screwdriver, reusable
ISOLA SPINE SYSTEM LOW PROFILE HOOK DRIVER 4.75mm
DEPUY SPINE, LLC
205124
Not in Commercial Distribution

  • 10705034001661 ()
205124

  • Orthopaedic implant driver
ISOLA SPINE SYSTEM HEXDRIVER
DEPUY SPINE, LLC
205055
Not in Commercial Distribution

  • 10705034001494 ()
205055

  • Orthopaedic implant driver
ISOLA SPINE SYSTEM RETAINING HEX DRIVER 3.18mm
DEPUY SPINE, LLC
205053
In Commercial Distribution

  • 10705034001470 ()
205053

  • Orthopaedic implant driver
ISOLA SYSTEM MINI HEXDRIVER 3.18mm
DEPUY SPINE, LLC
205051
Not in Commercial Distribution

  • 10705034001456 ()
205051

  • Orthopaedic implant driver
ISOLA SPINE SYSTEM SET SCREW WRENCH (HEX) 3.18mm
DEPUY SPINE, LLC
205050
Not in Commercial Distribution

  • 10705034001449 ()
205050

  • Orthopaedic implant driver
ISOLA SPINE SYSTEM HOOK DRIVER 6.35mm
DEPUY SPINE, LLC
205025
Not in Commercial Distribution

  • 10705034001241 ()
205025

  • Orthopaedic implant driver
ISOLA SPINE SYSTEM CONNECTOR POSITIONER
DEPUY SPINE, LLC
205023
In Commercial Distribution

  • 10705034001234 ()
205023

  • Orthopaedic implant driver
ISOLA SPINE SYSTEM ROD PUSHER
DEPUY SPINE, LLC
205015
In Commercial Distribution

  • 10705034001197 ()
205015

  • Orthopaedic implant driver
TIMX LOW BACK SYSTEM HEXLOBE DRIVER
DEPUY SPINE, LLC
202586
Not in Commercial Distribution

  • 10705034000596 ()
202586

  • Orthopaedic implant driver
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