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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LOCATOR ABUTMENT DRIVER (GOLD END)
SWEDEN & MARTINA SPA
8390
In Commercial Distribution

  • 00893202000189 ()
8390

  • Dental implant suprastructure, permanent, preformed
LOCATOR® DRIVER FOR RATCHET, L 15.0 MM
Zest Anchors, LLC
08395
In Commercial Distribution

  • 00893202000127 ()

  • Length: 15 Millimeter


  • Surgical screwdriver, reusable
INSTRUMENT FOR BONE ANCHOR/ WINGLETS AND BLADE EXTENSION
Synthes GmbH
03.816.030
In Commercial Distribution

  • 07611819518711 ()
  • H981038160300 ()
  • 10705034730783 ()
03816030

  • Surgical screwdriver, reusable
SCREWDRIVER
Synthes GmbH
03.816.010
In Commercial Distribution

  • 07611819518643 ()
  • H981038160100 ()
  • 10705034730660 ()
03816010

  • Surgical screwdriver, reusable
RETRACTOR EXTENSION DRIVER
Synthes GmbH
03.809.923
In Commercial Distribution

  • 07611819325852 ()
  • H981038099230 ()
  • 10705034726717 ()
03809923

  • Surgical screwdriver, reusable
RETRACTOR BLADE DRIVER
Synthes GmbH
03.809.857
In Commercial Distribution

  • 07611819325654 ()
  • H981038098570 ()
  • 10705034726267 ()
03809857

  • Surgical screwdriver, reusable
XRL LARGE ENDPLATE SCREWDRIVER TIP
Synthes GmbH
03.807.352
In Commercial Distribution

  • H981038073520 ()
  • 10705034723266 ()
  • 07611819406926 ()
03807352

  • Surgical screwdriver, reusable
XRL MEDIUM ENDPLATE SCREWDRIVER TIP
Synthes GmbH
03.807.351
In Commercial Distribution

  • H981038073510 ()
  • 10705034723259 ()
  • 07611819406315 ()
03807351

  • Surgical screwdriver, reusable
SLAP HAMMER
Synthes GmbH
03.803.055
In Commercial Distribution

  • 07611819941106 ()
  • H981038030550 ()
  • 10705034722580 ()
03803055

  • Surgical mallet
TAPERED U-JOINT DRIVER FOR SYNFIX MINI-OPEN
Synthes GmbH
03.802.431
In Commercial Distribution

  • H981038024310 ()
  • 10705034722436 ()
03802431

  • Surgical screwdriver, reusable
SCREWDRIVER FOR SYNFIX(TM)-LR
Synthes GmbH
03.802.037
In Commercial Distribution

  • 07611819297210 ()
  • H981038020370 ()
  • 10705034722238 ()
03802037

  • Surgical screwdriver, reusable
SCREWDRIVER SHAFT T15
Synthes GmbH
03.802.030
In Commercial Distribution

  • H981038020300 ()
  • 10705034722160 ()
03802030

  • Surgical screwdriver, reusable
STAPLE IMPACTOR
SYNTHES (U.S.A.) LP
03.650.000
Not in Commercial Distribution

  • 07611819928213 ()
  • H981036500000 ()
  • 10705034720883 ()
03650000

  • Surgical screwdriver, reusable
REMOVAL SCREWDRIVER
Synthes GmbH
03.647.971
In Commercial Distribution

  • H981036479710 ()
  • 10705034720791 ()
  • 07611819404472 ()
03647971

  • Surgical screwdriver, reusable
Final Driver Open
NEXXT SPINE, LLC
I20-10-15
In Commercial Distribution

  • 00889929051870 ()


  • General internal orthopaedic fixation system implantation kit
Final Driver MIS
NEXXT SPINE, LLC
I20-10-14
In Commercial Distribution

  • 00889929051603 ()


  • General internal orthopaedic fixation system implantation kit
Final Driver
NEXXT SPINE, LLC
I20-10-11
In Commercial Distribution

  • 00889929051351 ()


  • General internal orthopaedic fixation system implantation kit
T-25 In Situ Driver
NEXXT SPINE, LLC
I20-10-02
In Commercial Distribution

  • 00889929050293 ()


  • General internal orthopaedic fixation system implantation kit
Lumbar Straight Driver Sleeve
NEXXT SPINE, LLC
I63-22-01
In Commercial Distribution

  • 00889929045855 ()


  • General internal orthopaedic fixation system implantation kit
DISTRACTOR PIN DRIVER
Synthes GmbH
03.841.058
In Commercial Distribution

  • 07611819473171 ()
  • H981038410580 ()
  • 10705034732381 ()
03841058

  • Surgical screwdriver, reusable
2.0MM HEX SCREWDRIVER
SYNTHES (U.S.A.) LP
03.820.143
In Commercial Distribution

  • 07611819995789 ()
  • H981038201430 ()
  • 10705034731803 ()
03820143

  • Surgical screwdriver, reusable
SLOTTED MALLET
Synthes GmbH
03.820.113
In Commercial Distribution

  • 07611819945142 ()
  • H981038201130 ()
  • 10705034731544 ()
03820113

  • Surgical mallet
SELF-RETAINING SCREWDRIVER
Synthes GmbH
03.820.101
In Commercial Distribution

  • 07611819945029 ()
  • H981038201010 ()
  • 10705034731377 ()
03820101

  • Surgical screwdriver, reusable
ORACLE SLAP HAMMER
Synthes GmbH
03.809.972
In Commercial Distribution

  • 07611819374027 ()
  • H981038099720 ()
  • 10705034726908 ()
03809972

  • Surgical mallet
SLAP HAMMER WITH QUICK RELEASE
Synthes GmbH
03.809.690
In Commercial Distribution

  • 07611819588271 ()
  • H981038096900 ()
  • 10705034725680 ()
03809690

  • Surgical mallet
Lock Bipolar Femoral Head - Pusher Liner
LIMACORPORATE SPA
9055.27.010
In Commercial Distribution

  • 08033390301312 ()
9055.27.010

  • Orthopaedic implant driver
TEMA Elbow - T15 Screwdriver Shaft for Axle Removal
LIMACORPORATE SPA
9015.90.008
In Commercial Distribution

  • 08033390290654 ()
9015.90.008

  • Surgical screwdriver, reusable
PRIMA TT Glenoid - Glenosphere Pusher
LIMACORPORATE SPA
9019.74.152
In Commercial Distribution

  • 08033390272698 ()
9019.74.152

  • Orthopaedic implant driver
Hand Tool #3L Male hex driver 3.3mm (for 6,7 & 8mm ITI implants
Suncoast Dental, Inc
Hand Tool / HT.03L
In Commercial Distribution

  • 00083208367847 ()

  • Hand Tool #3L Male hex driver 3.3mm (for 6,7 & 8mm ITI implants
HT.03L

  • Dental implant system
Hand Tool #32A Driver for 4.0mm angled one piece Implant (CBA)
Suncoast Dental, Inc
Hand Tool / HT.32A
In Commercial Distribution

  • 00083208320040 ()

  • Hand Tool #32A Driver for 4.0mm angled one piece Implant (CBA)
HT.32A

  • Dental implant system
Hand Tool #31A Driver for 3.5mm angled one piece Implant (CBA)
Suncoast Dental, Inc
Hand Tool / HT.31A
In Commercial Distribution

  • 00083208310041 ()

  • Hand Tool #31A Driver for 3.5mm angled one piece Implant (CBA)
HT.31A

  • Dental implant system
Hand Tool #30 Integrity .050 Hex driver with handle for Integrity abutments, healing cuffs, cover screws, and 2mm screws
Suncoast Dental, Inc
Hand Tool / HT.30
In Commercial Distribution

  • 00083208300042 ()

  • Hand Tool #30 Integrity .050 Hex driver with handle for Integrity abutments, healing cuffs, cover screws, and 2-2.5mm screws
HT.30

  • Dental implant system
Hand Tool #29 Integrity .050 latch grip driver for Integrity abutments, healing cuffs, cover screws, and 2mm screws
Suncoast Dental, Inc
Hand Tool / HT.29
In Commercial Distribution

  • 00083208290046 ()

  • Hand Tool #29 Integrity .050 lach grip driver for Integrity abutments, healing cuffs, cover screws, and 2-2.5mm screws
HT.29

  • Dental implant system
Hand Tool #28 thumb screw driver for 4mm square
Suncoast Dental, Inc
Hand Tool / HT.28
Not in Commercial Distribution

  • 00083208280047 ()

  • Hand Tool #28 thumb screw driver for 4mm square
HT.28

  • Surgical screwdriver, reusable
Hand Tool #26 Adapter for standard 4mm square drive ratchet to fit Tatum drivers
Suncoast Dental, Inc
Hand Tool / HT.26
In Commercial Distribution

  • 00083208260049 ()

  • Hand Tool #26 Adapter for standard 4mm square drive ratchet to fit Tatum drivers
HT.26

  • Dental torque wrench adaptor
Adjustable Torque wrench - take 4mm square head drivers/adapters - can be adjusted between 15-60Ncm
Suncoast Dental, Inc
Adjustable Torque Wrench
In Commercial Distribution

  • 00083208230448 ()

  • 4mm Square Head
Torque Wrench Adjustable

  • Dental torque wrench
"Break Away" 35 Ncm Torque Wrench - 4mm square head to fit drivers and adapters. 35Ncm max torque.
Suncoast Dental, Inc
Torque Wrench 35 Ncm
In Commercial Distribution

  • 00083208230431 ()

  • 4mm Square Head
Torque Wrench 35 Ncm

  • Dental torque wrench
"Break Away" 30 Ncm Torque Wrench - 4mm square head to fit drivers and adapters. 30Ncm max torque.
Suncoast Dental, Inc
Torque Wrench 30 Ncm
In Commercial Distribution

  • 00083208230424 ()

  • 4mm Square Head
Torque Wrench 30 Ncm

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

  • 08033390207935 ()
9015.90.006

  • Surgical screwdriver, reusable
Hand Tool #22 Driver for 5.0mm one piece ball post Implant (SB)
Suncoast Dental, Inc
Hand Tool / HT.22
In Commercial Distribution

  • 00083208220043 ()

  • Hand Tool #22 Driver for 5.0mm one piece ball post Implant (SB)
HT.22

  • Dental implant system
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