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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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TAURUS - 00841732132627

Hexalobe Driver, Self-Retaining, Cannulated, T25, Short
CTL Medical Corporation
059.7105
In Commercial Distribution

  • 00841732132627 ()


  • Internal spinal fixation procedure kit, reusable

VALEO - 00841732162792

Casper Pin Driver
CTL Medical Corporation
91.002.1005
In Commercial Distribution

  • 00841732162792 ()


  • General internal orthopaedic fixation system implantation kit

ACP - 00195377096166

ACP Driver, Screw & Lock Optimized Taper
Nuvasive, Inc.
7786751
In Commercial Distribution

  • 00195377096166 ()


  • Internal spinal fixation procedure kit, reusable

ReLine - 00195377092243

RELINE C Driver, Reduction Screw
Nuvasive, Inc.
3999005
In Commercial Distribution

  • 00195377092243 ()


  • Internal spinal fixation procedure kit, reusable

Screwdriver Revision - 04057217006741

No Description
Z-Medical GmbH + Co. KG
A06 310
In Commercial Distribution

  • 04057217006741 ()


  • Surgical screwdriver, reusable

Screwdriver Pedicle Screw - 04057217006734

No Description
Z-Medical GmbH + Co. KG
A06 006
In Commercial Distribution

  • 04057217006734 ()


  • Surgical screwdriver, reusable

Screwdriver Ini - 04057217006727

No Description
Z-Medical GmbH + Co. KG
A06 005
In Commercial Distribution

  • 04057217006727 ()


  • Surgical screwdriver, reusable

NA - 00195377164551

CoRoent SI Driver, Angled Freehand XL
Nuvasive, Inc.
Z700104
In Commercial Distribution

  • 00195377164551 ()


  • Internal spinal fixation procedure kit, reusable

NA - 00195377163493

NAV.S Reline C Driver, Locking
Nuvasive, Inc.
Z700334
In Commercial Distribution

  • 00195377163493 ()


  • Internal spinal fixation procedure kit, reusable

NA - 00195377163448

MOD-EX PL Driver, Expansion Post Sleeve
Nuvasive, Inc.
Z500164
In Commercial Distribution

  • 00195377163448 ()


  • Internal spinal fixation procedure kit, reusable

NA - 00195377162205

ACP Driver, 6.35" Primary Lock Sleeve
Nuvasive, Inc.
Z700333-01
In Commercial Distribution

  • 00195377162205 ()


  • Internal spinal fixation procedure kit, reusable

NA - 00195377162168

MOD-EX PL Driver, Expansion Post Sleeve
Nuvasive, Inc.
Z500161-02
In Commercial Distribution

  • 00195377162168 ()


  • Internal spinal fixation procedure kit, reusable

NA - 00195377162151

MOD-EX PL Driver, Expansion Ant Sleeve
Nuvasive, Inc.
Z500161-01
In Commercial Distribution

  • 00195377162151 ()


  • Internal spinal fixation procedure kit, reusable

XLIF - 00195377160058

XLIF Prone Removal Driver
Nuvasive, Inc.
3250060
In Commercial Distribution

  • 00195377160058 ()


  • Internal spinal fixation procedure kit, reusable

XLIF - 00195377160041

XLIF Prone Simple Driver
Nuvasive, Inc.
3250050
In Commercial Distribution

  • 00195377160041 ()


  • Internal spinal fixation procedure kit, reusable

LnK Spinal Instrument System - 08806344397880

T25 90 Deg Static Driver
L&K BIOMED CO. ,LTD.
1947-FA-125S90D
In Commercial Distribution

  • 08806344397880 ()
1947-FA-125S90D

  • Orthopaedic prosthesis implantation positioning instrument, reusable

LnK Spinal Instrument System - 08806344397859

Fixation Shim Driver
L&K BIOMED CO. ,LTD.
1947-FA-125SFSHIMD
In Commercial Distribution

  • 08806344397859 ()
1947-FA-125SFSHIMD

  • Orthopaedic prosthesis implantation positioning instrument, reusable

LnK Spinal Instrument System - 08806344397842

Pedicle Shim Rescue Driver
L&K BIOMED CO. ,LTD.
1947-CMP-125SPRES
In Commercial Distribution

  • 08806344397842 ()
1947-CMP-125SPRES

  • Orthopaedic prosthesis implantation positioning instrument, reusable

LnK Spinal Instrument System - 08806344397330

DUAL END SET SCREW DRIVER
L&K BIOMED CO. ,LTD.
CS02-CM16
In Commercial Distribution

  • 08806344397330 ()
CS02-CM16

  • Orthopaedic prosthesis implantation positioning instrument, reusable

ALPHALOK Plating System - 00841731129710

RECON In Situ Plate Bender
VILEX LLC
TL-BEND
In Commercial Distribution

  • 00841731129710 ()
TL-BEND

  • Surgical screwdriver, reusable

Dynex - 00841731124661

Hex Driver, 3mm
VILEX LLC
DF-ZHX02-30
In Commercial Distribution

  • 00841731124661 ()


  • Surgical screwdriver, reusable

Vilex Jones Fracture Tool - 00841731123206

Driver, Jones T20 Hexalobe, Solid, Non Self Retaining
VILEX IN TENNESSEE, INC.
JF-SDT20-NSR
In Commercial Distribution

  • 00841731123206 ()


  • Surgical screwdriver, reusable

Vilex Jones Fracture Tool - 00841731123190

Driver, Jones T20 Hexalobe, Non Self Retaining
VILEX IN TENNESSEE, INC.
JF-DT20-NSR
In Commercial Distribution

  • 00841731123190 ()


  • Surgical screwdriver, reusable

Vilex Jones Fracture Tool - 00841731123183

Driver, Jones T20 Hexalobe, Solid Self Retaining
VILEX IN TENNESSEE, INC.
JF-SDT20
In Commercial Distribution

  • 00841731123183 ()


  • Surgical screwdriver, reusable

A.L.P.S. mvX™ - 00196449016501

2.4MM OVERDRILL
Tyber Medical LLC
770003240
In Commercial Distribution

  • 00196449016501 ()
770003240

  • Cannulated surgical drill bit, single-use

A.L.P.S. mvX™ - 00196449016495

2.0MM OVERDRILL
Tyber Medical LLC
770003200
In Commercial Distribution

  • 00196449016495 ()
770003200

  • Cannulated surgical drill bit, single-use

A.L.P.S. mvX™ - 00196449016488

1.8MM DRILL SHORT
Tyber Medical LLC
770002180
In Commercial Distribution

  • 00196449016488 ()
770002180

  • Cannulated surgical drill bit, single-use

A.L.P.S. mvX™ - 00196449016471

1.5MM DRILL SHORT
Tyber Medical LLC
770002150
In Commercial Distribution

  • 00196449016471 ()
770002150

  • Cannulated surgical drill bit, single-use

A.L.P.S. mvX™ - 00196449016457

1.0MM DRILL
Tyber Medical LLC
770002100
In Commercial Distribution

  • 00196449016457 ()
770002100

  • Cannulated surgical drill bit, single-use

A.L.P.S. mvX™ - 00196449011728

3.0MM DRILL
Tyber Medical LLC
770900006
In Commercial Distribution

  • 00196449011728 ()
770900006

  • Cannulated surgical drill bit, single-use

A.L.P.S. mvX™ - 00196449011711

2.7MM DRILL
Tyber Medical LLC
770900005
In Commercial Distribution

  • 00196449011711 ()
770900005

  • Cannulated surgical drill bit, single-use

A.L.P.S. mvX™ - 00196449011704

2.0MM DRILL
Tyber Medical LLC
770900004
In Commercial Distribution

  • 00196449011704 ()
770900004

  • Cannulated surgical drill bit, single-use

A.L.P.S. mvX™ - 00196449011681

T8 CANNULATED DRIVER
Tyber Medical LLC
770900002
In Commercial Distribution

  • 00196449011681 ()
770900002

  • Surgical screwdriver, single-use

A.L.P.S. mvX™ - 00196449009206

0.9MM DRILL
Tyber Medical LLC
770002090
In Commercial Distribution

  • 00196449009206 ()
770002090

  • Cannulated surgical drill bit, single-use

LEOS - 00196449001767

LEOS Ø2.0mm Subchondral Drill
Tyber Medical LLC
7624-2820
In Commercial Distribution

  • 00196449001767 ()
7624-2820

  • Cannulated surgical drill bit, single-use

LEOS - 00196449001743

LEOS T15 Retention Driver
Tyber Medical LLC
7624-3915
In Commercial Distribution

  • 00196449001743 ()
7624-3915

  • Orthopaedic implant driver

LEOS - 00196449001729

LEOS Ø4.0 Lag Drill
Tyber Medical LLC
7624-2940
In Commercial Distribution

  • 00196449001729 ()
7624-2940

  • Cannulated surgical drill bit, single-use

LEOS - 00196449001705

LEOS Ø2.4 Drill
Tyber Medical LLC
7624-2924
In Commercial Distribution

  • 00196449001705 ()
7624-2924

  • Cannulated surgical drill bit, single-use

LEOS - 00196449001699

LEOS Ø2.0 Drill
Tyber Medical LLC
7624-2920
In Commercial Distribution

  • 00196449001699 ()
7624-2920

  • Cannulated surgical drill bit, single-use

Drill Extension - 08806388225699

Common Spring Type
Megagen Implant Co. Ltd
MDE150
In Commercial Distribution

  • 08806388225699 ()
MDE150

  • Surgical screwdriver, reusable

E3D®-C Interbody System - 00195860025611

SPLIT TIP DRIVER
Evolution Spine LLC
130-A019
In Commercial Distribution

  • 00195860025611 ()
130-A019

  • Surgical screwdriver, reusable

E3D®-C Interbody System - 00195860025604

FI'ED ANGLE DRIVER
Evolution Spine LLC
130-A018
In Commercial Distribution

  • 00195860025604 ()
130-A018

  • Surgical screwdriver, reusable

Right Angle Driver - 08806388225989

Common Hex 1.25/ Short
Megagen Implant Co. Ltd
MDR125S
In Commercial Distribution

  • 08806388225989 ()
MDR125S

  • Surgical screwdriver, reusable

Right Angle Driver - 08806388225972

Common Hex 1.2/ Ultra
Megagen Implant Co. Ltd
MDR120SS
In Commercial Distribution

  • 08806388225972 ()
MDR120SS

  • Surgical screwdriver, reusable

Right Angle Driver - 08806388225965

Common Hex 1.2/ Short
Megagen Implant Co. Ltd
MDR120S
In Commercial Distribution

  • 08806388225965 ()
MDR120S

  • Surgical screwdriver, reusable

Right Angle Driver - 08806388225958

Common Hex 1.2/ Long
Megagen Implant Co. Ltd
MDR120L
In Commercial Distribution

  • 08806388225958 ()
MDR120L

  • Surgical screwdriver, reusable

Right Angle Driver - 08806388225941

Common Hex=1.2/ Extra Long
Megagen Implant Co. Ltd
MDR120EL
In Commercial Distribution

  • 08806388225941 ()
MDR120EL

  • Surgical screwdriver, reusable

Right Angle Driver - 08806388225934

Common Hex 0.9/ Ultra
Megagen Implant Co. Ltd
MDR090SS
In Commercial Distribution

  • 08806388225934 ()
MDR090SS

  • Surgical screwdriver, reusable

Right Angle Driver - 08806388225927

Common Hex 0.9/ Short
Megagen Implant Co. Ltd
MDR090S
In Commercial Distribution

  • 08806388225927 ()
MDR090S

  • Surgical screwdriver, reusable

Right Angle Driver - 08806388225910

Common Hex 0.9/ Long
Megagen Implant Co. Ltd
MDR090L
In Commercial Distribution

  • 08806388225910 ()
MDR090L

  • Surgical screwdriver, reusable
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