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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No Description
W.H. Holden, Inc.
10-5170N
In Commercial Distribution

  • D928105170N0 ()


  • Surgical screwdriver, reusable
No Description
W.H. Holden, Inc.
10-5170L
In Commercial Distribution

  • D928105170L0 ()


  • Surgical screwdriver, reusable
No Description
W.H. Holden, Inc.
10-5170EVD
In Commercial Distribution

  • D928105170EVD0 ()


  • Surgical screwdriver, reusable
No Description
W.H. Holden, Inc.
10-5170C
In Commercial Distribution

  • D928105170C0 ()


  • Surgical screwdriver, reusable
No Description
W.H. Holden, Inc.
10-5170B
In Commercial Distribution

  • D928105170B0 ()


  • Surgical screwdriver, reusable
No Description
W.H. Holden, Inc.
10-5170A-MTOS
In Commercial Distribution

  • D928105170AMTOS0 ()


  • Surgical screwdriver, reusable
No Description
W.H. Holden, Inc.
10-5170A
In Commercial Distribution

  • D928105170A0 ()


  • Surgical screwdriver, reusable
No Description
W.H. Holden, Inc.
10-5170
In Commercial Distribution

  • D9281051700 ()


  • Dental osteotome
DRIVER EX0512007 5.5 MAS ATT HANDLE
MEDTRONIC SOFAMOR DANEK, INC.
EX0512007
In Commercial Distribution

  • 00643169178366 ()


  • Orthopaedic implant driver
DRIVER EX0412265 MAS SCREW EXTENSION
MEDTRONIC SOFAMOR DANEK, INC.
EX0412265
In Commercial Distribution

  • 00643169178335 ()


  • Orthopaedic implant driver
SCREWDRIVER EX0412132 SHORT 5.5/6.0 MAS
MEDTRONIC SOFAMOR DANEK, INC.
EX0412132
In Commercial Distribution

  • 00643169177932 ()


  • Orthopaedic implant driver
DRIVER EX0412114 5.5 LOCK BUTTON SHORT
MEDTRONIC SOFAMOR DANEK, INC.
EX0412114
In Commercial Distribution

  • 00643169177802 ()


  • Orthopaedic implant driver
SCREWDRIVER EX0412267 PEEK MAS
MEDTRONIC SOFAMOR DANEK, INC.
EX0412267
In Commercial Distribution

  • 00643169177789 ()


  • Surgical screwdriver, reusable
DRIVER EX0412155 6.35 PROV T-HANDLE
MEDTRONIC SOFAMOR DANEK, INC.
EX0412155
In Commercial Distribution

  • 00643169177178 ()


  • Surgical drill guide, reusable
EXTENDER 7578302 5.5/6.0 EXTENDER BODY
MEDTRONIC SOFAMOR DANEK, INC.
7578302
In Commercial Distribution

  • 00643169177055 ()


  • Surgical screwdriver, reusable
DRIVER 5584928 FAS
MEDTRONIC SOFAMOR DANEK, INC.
5584928
In Commercial Distribution

  • 00643169177031 ()


  • Surgical screwdriver, reusable
DRIVER 5584339 5.5/6.0 EAC FAS
MEDTRONIC SOFAMOR DANEK, INC.
5584339
In Commercial Distribution

  • 00643169175648 ()


  • Orthopaedic implant driver
DRIVER EX0312489 XL PROVISIONAL
MEDTRONIC SOFAMOR DANEK, INC.
EX0312489
In Commercial Distribution

  • 00643169170537 ()


  • Surgical drill guide, reusable
NGO motor driver 1503185-001 Update of the motor control board of the console OPTIMA MX: Added a switch motor on top of the motor board that can control up to 3 motors.
Bien-Air Dental SA
1503185-001
In Commercial Distribution

  • J00715031850011 ()


  • Dental surgical power tool motor, electric
iChiropro console a driver designed to drive Bien-Air Dental SA's dental micromotors, via an Apple iDevice (iPod or iPad).
Bien-Air Dental SA
1400052
In Commercial Distribution

  • J00714000520521 ()
1400052

  • Surgical power tool system control unit, line-powered
  • Dental treatment application software
iChiropro console a driver designed to drive Bien-Air Dental SA's dental micromotors, via an Apple iDevice (iPod or iPad).
Bien-Air Dental SA
1400051
In Commercial Distribution

  • J00714000510511 ()
1400051

  • Surgical power tool system control unit, line-powered
PIN DRIVER EX0312473 SHORTENED
MEDTRONIC SOFAMOR DANEK, INC.
EX0312473
In Commercial Distribution

  • 00643169184220 ()


  • Surgical drill guide, reusable
DRIVER EX0512097 SHORT CANN. 5.5 RMAS
MEDTRONIC SOFAMOR DANEK, INC.
EX0512097
In Commercial Distribution

  • 00643169181762 ()


  • Orthopaedic implant driver
DRIVER EX0212740 3.2MM BALL TIP
MEDTRONIC SOFAMOR DANEK, INC.
EX0212740
In Commercial Distribution

  • 00643169167117 ()


  • Orthopaedic implant driver
DRIVER EX0312093 T-27 EXTENDED SHAFT
MEDTRONIC SOFAMOR DANEK, INC.
EX0312093
In Commercial Distribution

  • 00643169165601 ()


  • Surgical drill guide, reusable
DRIVER 5484901 4.75 RETAINING MAS DRIVER
MEDTRONIC SOFAMOR DANEK, INC.
5484901
In Commercial Distribution

  • 00643169163089 ()


  • Surgical screwdriver, reusable
DRIVER 5584099 5.5/6.0 RETAINING MAS
MEDTRONIC SOFAMOR DANEK, INC.
5584099
In Commercial Distribution

  • 00643169163065 ()


  • Surgical screwdriver, reusable
DRIVER 5584922 T-25 BALL ENDED DRIVER
MEDTRONIC SOFAMOR DANEK, INC.
5584922
In Commercial Distribution

  • 00643169163041 ()


  • Surgical screwdriver, reusable
DRIVER 5584999 MAS DRIVER
MEDTRONIC SOFAMOR DANEK, INC.
5584999
In Commercial Distribution

  • 00643169163034 ()


  • Surgical screwdriver, reusable
DRIVER EX0312670 BALL HANDLE
MEDTRONIC SOFAMOR DANEK, INC.
EX0312670
In Commercial Distribution

  • 00643169174177 ()


  • Orthopaedic implant driver
SCREWDRIVER EX1011036 T20
MEDTRONIC SOFAMOR DANEK, INC.
EX1011036
In Commercial Distribution

  • 00643169174160 ()


  • Surgical screwdriver, reusable
DRIVER EX0412058 SHORT T25
MEDTRONIC SOFAMOR DANEK, INC.
EX0412058
In Commercial Distribution

  • 00643169173293 ()


  • Surgical drill guide, reusable
Hard metal tip, straight (for Eby band seater REF 051-023-00)
DENTAURUM GmbH & Co.KG
051-025-00
Not in Commercial Distribution

  • J011051025000 ()


  • Orthodontic metal band pusher
Eby band seater, curved, Stainless steel
DENTAURUM GmbH & Co.KG
051-023-00
Not in Commercial Distribution

  • J011051023000 ()


  • Orthodontic metal band pusher
Exchange Tip,Straight
DENTAURUM GmbH & Co.KG
051-022-00
Not in Commercial Distribution

  • J011051022000 ()


  • Orthodontic metal band pusher
Drill, Size Dia. 2.3x16 mm
K2M, INC.
6808-90028
In Commercial Distribution

  • 10888857261761 ()
6808-90028

  • Cannulated surgical drill bit, single-use
Drill, Size Dia. 2.3x14 mm
K2M, INC.
6808-90027
In Commercial Distribution

  • 10888857261754 ()
6808-90027

  • Cannulated surgical drill bit, single-use
Drill, Size Dia. 2.3x12 mm
K2M, INC.
6808-90026
In Commercial Distribution

  • 10888857261747 ()
6808-90026

  • Cannulated surgical drill bit, single-use
Drill, Size Dia. 2.3x10 mm
K2M, INC.
6808-90025
In Commercial Distribution

  • 10888857261730 ()
6808-90025

  • Cannulated surgical drill bit, single-use
Single Barrel Drill, Size Dia. 2.3x16 mm
K2M, INC.
6808-90022
In Commercial Distribution

  • 10888857261686 ()
6808-90022

  • Cannulated surgical drill bit, single-use
Single Barrel Drill, Size Dia. 2.3x14 mm
K2M, INC.
6808-90021
In Commercial Distribution

  • 10888857261679 ()
6808-90021

  • Cannulated surgical drill bit, single-use
Single Barrel Drill, Size Dia. 2.3x12 mm
K2M, INC.
6808-90020
In Commercial Distribution

  • 10888857261662 ()
6808-90020

  • Cannulated surgical drill bit, single-use
Single Barrel Drill, Size Dia. 2.3x10 mm
K2M, INC.
6808-90015
In Commercial Distribution

  • 10888857261655 ()
6808-90015

  • Cannulated surgical drill bit, single-use
Fixation Pin Driver, Size 15 Long
K2M, INC.
SP-1361
In Commercial Distribution

  • 10888857247758 ()

  • Size 15 Hexalobe
SP-1361

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Capture Driver, Sleeve
K2M, INC.
SP-1344-02
In Commercial Distribution

  • 10888857247734 ()
SP-1344-02

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Universal Driver Size Tapered, Size 20
K2M, INC.
SP-1282
In Commercial Distribution

  • 10888857247659 ()
SP-1282

  • Surgical screwdriver, reusable
Inner Shaft Removal Driver
K2M, INC.
6712-90001
In Commercial Distribution

  • 10888857247321 ()
6712-90001

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Retaining Driver Size 13
K2M, INC.
6712-90000
In Commercial Distribution

  • 10888857247314 ()
6712-90000

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Capture Driver Size 25
K2M, INC.
SP-1344-01
In Commercial Distribution

  • 10888857247185 ()
SP-1344-01

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Fixation Pin Driver Size 15
K2M, INC.
K2-27-2014-01
In Commercial Distribution

  • 10888857243842 ()
K2-27-2014-01

  • Orthopaedic prosthesis implantation positioning instrument, reusable
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