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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DRVR TAG 3.7MM WDG.ARTHROSCOP.
Smith & Nephew, Inc.
013190
In Commercial Distribution

  • 03596010090362 ()
013190

  • Surgical screwdriver, reusable
SPECTRON EF FEMORAL DRIVER
Smith & Nephew, Inc.
119817
In Commercial Distribution

  • 03596010058805 ()
119817

  • Orthopaedic inorganic implant inserter/extractor, reusable
4.0MM CANNULATED SCREWDRIVER
Smith & Nephew, Inc.
117070
In Commercial Distribution

  • 03596010054838 ()
117070

  • Surgical screwdriver, reusable
INTRAMEDULLARY HIP SCREW DRIVER
Smith & Nephew, Inc.
115160
In Commercial Distribution

  • 03596010052759 ()
115160

  • Surgical screwdriver, reusable
HEX SCREWDRIVER FOR 4.5MM AND 6.5MM BONE SCREWS
Smith & Nephew, Inc.
115035
In Commercial Distribution

  • 03596010052063 ()
115035

  • Surgical screwdriver, reusable
HEX-FIX ADD-A-CLAMP
Smith & Nephew, Inc.
112738
In Commercial Distribution

  • 03596010042507 ()
112738

  • External orthopaedic fixation system, reusable
HEX-FIX STRAIGHT HEX DRIVER
Smith & Nephew, Inc.
112719
In Commercial Distribution

  • 03596010042316 ()
112719

  • Surgical screwdriver, reusable
HEX-FIX 90 DEGREE HEX DRIVER
Smith & Nephew, Inc.
112717
In Commercial Distribution

  • 03596010042309 ()
112717

  • Surgical screwdriver, reusable
HEX-FIX PIN DRIVER/ EXTRACTOR
Smith & Nephew, Inc.
112716
In Commercial Distribution

  • 03596010042293 ()
112716

  • Orthopaedic inorganic implant inserter/extractor, reusable
HEX-FIX METATARSAL PADDLE & CLAMP
Smith & Nephew, Inc.
112709
In Commercial Distribution

  • 03596010042231 ()
112709

  • External orthopaedic fixation system, reusable
RUSSELL TAYLOR SLIDE HAMMER
Smith & Nephew, Inc.
112011
In Commercial Distribution

  • 03596010040435 ()
112011

  • Surgical mallet
EXTRA PLASTIC DRIVING FACE
Smith & Nephew, Inc.
111561
In Commercial Distribution

  • 03596010039408 ()
111561

  • Orthopaedic implant impactor, reusable
FEMORAL PROSTHESIS DRIVER
Smith & Nephew, Inc.
111560
In Commercial Distribution

  • 03596010039392 ()
111560

  • Orthopaedic inorganic implant inserter/extractor, reusable
REPLACEMENT HEAD LT WT PLASTIC FOR 11 1421
Smith & Nephew, Inc.
111422
In Commercial Distribution

  • 03596010038838 ()
111422

  • Surgical mallet
COMBINATION MALLET 10 OZ
Smith & Nephew, Inc.
111421
Not in Commercial Distribution

  • 03596010038821 ()
111421

  • Surgical mallet
REPLACEMENT HEAD MED WT STAINLESS STEEL FOR 11 141
Smith & Nephew, Inc.
111418
In Commercial Distribution

  • 03596010038814 ()
111418

  • Surgical mallet
COMBINATION MALLET 20 OZ
Smith & Nephew, Inc.
111416
In Commercial Distribution

  • 03596010038791 ()
111416

  • Surgical mallet
FIXATION STAPLE DRIVER-EXTRACTOR
Smith & Nephew, Inc.
111138
In Commercial Distribution

  • 03596010037916 ()
111138

  • Orthopaedic inorganic implant inserter/extractor, reusable
ANGLED STAPLE DRIVER-EXTRACTOR
Smith & Nephew, Inc.
111132
In Commercial Distribution

  • 03596010037862 ()
111132

  • Orthopaedic inorganic implant inserter/extractor, reusable
TABLE FIXATION STAPLE DRIVER-EXTRACTOR
Smith & Nephew, Inc.
111130
In Commercial Distribution

  • 03596010037848 ()
111130

  • Orthopaedic inorganic implant inserter/extractor, reusable
EXTENSION ROD STAPLE DRIVER-EXTRACTOR
Smith & Nephew, Inc.
111129
In Commercial Distribution

  • 03596010037831 ()
111129

  • Orthopaedic inorganic implant inserter/extractor, reusable
STAPLE HAMMER
Smith & Nephew, Inc.
111127
In Commercial Distribution

  • 03596010037824 ()
111127

  • Surgical mallet
4-WAY COMBINATION SCREWDRIVER
Smith & Nephew, Inc.
110280
In Commercial Distribution

  • 03596010034663 ()
110280

  • Surgical screwdriver, reusable
PHILLIPS/CROSS-SLOT REPLACEMENT BLADE
Smith & Nephew, Inc.
110279
In Commercial Distribution

  • 03596010034656 ()
110279

  • Surgical screwdriver, reusable
SINGLE SLOT/CRUCIATE REPLACEMENT BLADE
Smith & Nephew, Inc.
110278
In Commercial Distribution

  • 03596010034649 ()
110278

  • Surgical screwdriver, reusable
SINGLE SL-PLUS SC-DRIVER XLGE
Smith & Nephew, Inc.
110267
In Commercial Distribution

  • 03596010034595 ()
110267

  • Surgical screwdriver, reusable
CRUCIATE SECREWDRIVER 203.2MM
Smith & Nephew, Inc.
110266
In Commercial Distribution

  • 03596010034588 ()
110266

  • Surgical screwdriver, reusable
SINGLE SLOT SCREWDRIVER 6.3MM X 260.3MM
Smith & Nephew, Inc.
110265
In Commercial Distribution

  • 03596010034571 ()
110265

  • Surgical screwdriver, reusable
6.5MM CANNULATED SCREWDRIVER WITH COUNTERSINK
Smith & Nephew, Inc.
110120
In Commercial Distribution

  • 03596010033970 ()
110120

  • Surgical screwdriver, reusable
Hand Tool #16 Driver for 4.0 and 4.5mm one piece Implant (SB) and Small Ball abutment
Suncoast Dental, Inc
Hand Tool / HT.16
In Commercial Distribution

  • 00083208160042 ()

  • Hand Tool #16 Driver for 4.0 and 4.5mm one piece Implant (SB) and Small Ball abutment
HT.16

  • Dental implant system
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
Hand Tool #13 Driver for 3.0mm angled one piece Implant (CBA)
Suncoast Dental, Inc
Hand Tool / HT.13
In Commercial Distribution

  • 00083208130045 ()

  • Hand Tool #13 Driver for 3.0mm angled one piece Implant (CBA)
HT.13

  • 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 #9 ADA shank 4x2mm male driver to fit Tapered, Screw and Integrity 3.7-5.0 Implants
Suncoast Dental, Inc
Hand Tool / HT.09
In Commercial Distribution

  • 00083208090042 ()

  • Hand Tool #9 ADA shank 4x2mm male driver to fit Tapered, Screw and Integrity 3.7-5.0 Implants
HT.09

  • Dental implant system
Ratchet and torque wrench extension to 2.5mm Pentagon. Fits: Straight, Tapered and Integrity Implants 3.7-5.0
Suncoast Dental, Inc
HT.07D
In Commercial Distribution

  • 00083208070341 ()

  • Duel Head, 3.5mm Hex & 2.5mm Pentagon
HT.07D

  • Surgical torque wrench adaptor
Torque Wrench Fits: Straight, Tapered and Integrity Implants 3.7-5.0
Suncoast Dental, Inc
HT.07U
In Commercial Distribution

  • 00083208070242 ()

  • 4.0mm Square Head & 2.5mm pentagon
HT.07U

  • Surgical torque wrench adaptor
Hand Tool #5 Female socket extension 4mm
Suncoast Dental, Inc
Hand Tool / HT.05
In Commercial Distribution

  • 00083208050046 ()

  • Hand Tool #5 Female socket extension 4mm to fit drivers HT.09/9L
HT.05

  • Dental implant system
Hand Tool #4 Hand screw driver
Suncoast Dental, Inc
Hand Tool / HT.04
In Commercial Distribution

  • 00083208030147 ()

  • Hand Tool #4 Hand Screw Driver
HT.04

  • Dental implant system
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