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
OSTEONIC CO.,Ltd.
PIS-0430-DRIVER
In Commercial Distribution

  • 08800071020967 ()


  • Surgical screwdriver, reusable
No Description
Izenimplant Co., Ltd.
BICD50LS
In Commercial Distribution

  • 08800070236864 ()


  • Surgical screwdriver, reusable
No Description
Izenimplant Co., Ltd.
BICD50SS
In Commercial Distribution

  • 08800070236857 ()


  • Surgical screwdriver, reusable
No Description
Izenimplant Co., Ltd.
BICD40LS
In Commercial Distribution

  • 08800070236840 ()


  • Surgical screwdriver, reusable
No Description
Izenimplant Co., Ltd.
BICD40SS
In Commercial Distribution

  • 08800070236833 ()


  • Surgical screwdriver, reusable
A non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device.
OSUNG MND Co., Ltd.
BSWDTL
In Commercial Distribution

  • 08800075611246 ()


  • Surgical screwdriver, reusable
A hand-held manual surgical instrument designed to strike a surface or another device (e.g., a surgical chisel, gouge, driver) to drive it during a surgical intervention. It is available in a variety of designs and materials; the shaft is typically made of metal (e.g., chromed iron (Fe) or high-grade stainless steel), but can be made of synthetic materials (e.g., Tufnol), and tapers distally to the head. The head is typically a solid, cylindrical shape normally being double-ended and made of solid (iron/steel) or shock-absorbing materials (e.g., rubber, plastic, or Tufnol). Also referred to as a surgical hammer it may also be used for autopsy. This is a reusable device.
OSUNG MND Co., Ltd.
ML29
In Commercial Distribution

  • 08800075610379 ()


  • Surgical mallet
A non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device.
OSUNG MND Co., Ltd.
BSWDTS
In Commercial Distribution

  • 08800075621108 ()


  • Surgical screwdriver, reusable
HiLAN perforator driver
Aesculap AG
GA742R
In Commercial Distribution

  • 04046963336264 ()
GA742R

  • Bone/joint surgical power tool motorized handpiece/set, pneumatic
microspeed uni perforator driver
Aesculap AG
GD685
In Commercial Distribution

  • 04046963336257 ()
GD685

  • Bone/joint surgical power tool motorized handpiece/set, electric, reusable
S4 SCREW DRIVER F/CANUL.POLYAXIAL SCREWS
Aesculap AG
FW270R
In Commercial Distribution

  • 04046963320324 ()
FW270R

  • Orthopaedic prosthesis implantation positioning instrument, reusable
S4 SCREW DRIVER F/CANUL.MONOAXIAL SCREWS
Aesculap AG
FW262R
In Commercial Distribution

  • 04046963319779 ()
FW262R

  • Orthopaedic prosthesis implantation positioning instrument, reusable
CRANIOPLATE 1.5 KIT 4MM CROS.BURR.COVER
Aesculap AG
FM992T
In Commercial Distribution

  • 04046963173852 ()
FM992T

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
CRANIOPLATE 1.5 KIT 4MM CROS.4HOLES STR.
Aesculap AG
FM991T
In Commercial Distribution

  • 04046963173845 ()
FM991T

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
CRANIOPLATE 1.5 KIT 4MM CROS.2HOLES STR.
Aesculap AG
FM990T
In Commercial Distribution

  • 04046963173821 ()
FM990T

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
S4 CANULATED T-HANDLE F/SCREW DRIVER
Aesculap AG
FW167R
In Commercial Distribution

  • 04046963172190 ()
FW167R

  • Orthopaedic prosthesis implantation positioning instrument, reusable
HEATH Mallet, 9 1/2" (240 mm), diam. 40 mm, peek handle, stainless steel, 850 g, 500 g
Aesculap AG
FL068R
In Commercial Distribution

  • 04046963112691 ()
FL068R

  • Surgical mallet
Cervical Screw Driver, AO Drive
Life Spine, Inc.
2015-0036
In Commercial Distribution

  • 00190837037369 ()
2015-0036

  • Spinal fixation plate, non-bioabsorbable
Cervical Screw Driver, Spin Cap Handle
Life Spine, Inc.
2014-0014
In Commercial Distribution

  • 00190837037345 ()
2014-0014

  • Spinal fixation plate, non-bioabsorbable
Locking Cap Final Torque Driver Shaft, Short
Life Spine, Inc.
2014-0004
In Commercial Distribution

  • 00190837037314 ()
2014-0004

  • Spinal fixation plate, non-bioabsorbable
Custom Cervical Screw Driver
Life Spine, Inc.
2011-0135
In Commercial Distribution

  • 00190837037291 ()
2011-0135

  • Spinal fixation plate, non-bioabsorbable
Sheathed Driver
Life Spine, Inc.
2010-0005
In Commercial Distribution

  • 00190837037260 ()
2010-0005

  • Spinal fixation plate, non-bioabsorbable
Custom Locking Bone Screw Driver
Life Spine, Inc.
2009-0070
In Commercial Distribution

  • 00190837036737 ()
2009-0070

  • Spinal fixation plate, non-bioabsorbable
Locking Fixation Pin Driver
Life Spine, Inc.
2009-0025
In Commercial Distribution

  • 00190837036706 ()
2009-0025

  • Spinal fixation plate, non-bioabsorbable
Sleeved Screw Driver
Life Spine, Inc.
2008-0046-02
In Commercial Distribution

  • 00190837036690 ()
2008-0046-02

  • Spinal fixation plate, non-bioabsorbable
Hexalobe Screw Driver
Life Spine, Inc.
113-105
In Commercial Distribution

  • 00190837036393 ()
113-105

  • Spinal fixation plate, non-bioabsorbable
Retainable Screw Hexalobe Driver
Life Spine, Inc.
113-1000
In Commercial Distribution

  • 00190837036386 ()
113-1000

  • Spinal fixation plate, non-bioabsorbable
Hexalobe Screw Driver
Life Spine, Inc.
113-013
In Commercial Distribution

  • 00190837036355 ()
113-013

  • Spinal fixation plate, non-bioabsorbable
ARX T25 POLYAXIAL SCREW DRIVER, NONCANNULATED
Life Spine, Inc.
175-146
In Commercial Distribution

  • 00190837035990 ()
175-146

  • Surgical screwdriver, reusable
Final Set Screw Driver
Life Spine, Inc.
175-122
In Commercial Distribution

  • 00190837035983 ()
175-122

  • Surgical screwdriver, reusable
Polyaxial Screw Head Adjuster
Life Spine, Inc.
175-115
In Commercial Distribution

  • 00190837035938 ()
175-115

  • Surgical screwdriver, reusable
Neo Remover Driver
Life Spine, Inc.
113-1004
In Commercial Distribution

  • 00190837035327 ()
113-1004

  • Spinal fixation plate, non-bioabsorbable
Installer Driver
Life Spine, Inc.
161-132
In Commercial Distribution

  • 00190837034283 ()
161-132

  • Spinal fixation plate, non-bioabsorbable
T30 Hexalobe Driver
Life Spine, Inc.
161-116
In Commercial Distribution

  • 00190837034252 ()
161-116

  • Spinal fixation plate, non-bioabsorbable
Hex Driver
Life Spine, Inc.
172-069
In Commercial Distribution

  • 00190837034023 ()
172-069

  • External orthopaedic fixation system, single-use
Hex Driver, A/O
Life Spine, Inc.
172-068
In Commercial Distribution

  • 00190837034016 ()
172-068

  • External orthopaedic fixation system, single-use
Polyaxial Screwdriver
Life Spine, Inc.
116-524
In Commercial Distribution

  • 00190837033019 ()
116-524

  • Surgical screwdriver, reusable
MIS COMPRESSOR-DISTRACTOR DRIVER
Life Spine, Inc.
116-572
In Commercial Distribution

  • 00190837032913 ()
116-572

  • Surgical screwdriver, reusable
Hexalobe T20 Screwdriver, Cannulated
Life Spine, Inc.
148-503
In Commercial Distribution

  • 00190837032821 ()
148-503

  • Surgical screwdriver, reusable
MIS POLYAXIAL SCREW DRIVER
Life Spine, Inc.
116-570
In Commercial Distribution

  • 00190837032753 ()
116-570

  • Surgical screwdriver, reusable
Locking Cap Driver
Life Spine, Inc.
116-508
In Commercial Distribution

  • 00190837032739 ()
116-508

  • Surgical screwdriver, reusable
Reduction Driver
Life Spine, Inc.
116-505
In Commercial Distribution

  • 00190837032722 ()
116-505

  • Surgical screwdriver, reusable
T30 Locking Cap Removal Driver
Life Spine, Inc.
2018-0017
In Commercial Distribution

  • 00190837032289 ()
2018-0017

  • Bone file/rasp, manual, reusable
T30 Driver
Life Spine, Inc.
113-084
In Commercial Distribution

  • 00190837079239 ()
113-084

  • Surgical retraction system, reusable
Locking Screw Driver
Life Spine, Inc.
152-188
In Commercial Distribution

  • 00190837079222 ()
152-188

  • Surgical screwdriver, reusable
Introduce Director
TDM Co., Ltd.
PPM-124
In Commercial Distribution

  • 08800043945397 ()
PPM-124

  • External orthopaedic fixation system, reusable
Rod Introducer
TDM Co., Ltd.
PPM-123
In Commercial Distribution

  • 08800043944666 ()
PPM-123

  • External orthopaedic fixation system, reusable
Container box
TDM Co., Ltd.
PPM-018
In Commercial Distribution

  • 08800043944642 ()
PPM-018

  • External orthopaedic fixation system, reusable
Flare Buster Tunneler, 370mm
TDM Co., Ltd.
PMI-072
In Commercial Distribution

  • 08800043935749 ()

  • Length: 370 Millimeter
PMI-053

  • External orthopaedic fixation system, reusable
Pectus Crane Screw Ø2.5x10mm
TDM Co., Ltd.
PSF-4210
In Commercial Distribution

  • 08800043934896 ()

  • Length: 170 Millimeter
PSF-4210

  • External orthopaedic fixation system, reusable
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