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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Modular 3mm OZAT Final Driver, Small Stature
Seaspine Orthopedics Corporation
97-6520
In Commercial Distribution

  • 10889981186142 ()
97-6520

  • Surgical screwdriver, reusable
1/4" Square T25 Driver, Small Stature
Seaspine Orthopedics Corporation
97-6519
In Commercial Distribution

  • 10889981186135 ()
97-6519

  • Surgical screwdriver, reusable
Screw Driver T25, Small Stature
Seaspine Orthopedics Corporation
97-6518
In Commercial Distribution

  • 10889981186128 ()
97-6518

  • Surgical screwdriver, reusable
Screw Driver 3mm OZAT, Small Stature
Seaspine Orthopedics Corporation
97-6517
In Commercial Distribution

  • 10889981186111 ()
97-6517

  • Surgical screwdriver, reusable
Split T25 Loader, Small Stature
Seaspine Orthopedics Corporation
97-6516
In Commercial Distribution

  • 10889981186104 ()
97-6516

  • Surgical screwdriver, reusable
Final Driver Shaft, Short Tip, Small Stature
Seaspine Orthopedics Corporation
97-6513
In Commercial Distribution

  • 10889981186074 ()
97-6513

  • Surgical screwdriver, reusable
Modular Angled Driver
Seaspine Orthopedics Corporation
SR-0360
In Commercial Distribution

  • 10889981182984 ()
SR-0360

  • Orthopaedic implant driver
Reduction Screw Driver, Locking, Short
Seaspine Orthopedics Corporation
90-1243
In Commercial Distribution

  • 10889981182755 ()
90-1243

  • Surgical screwdriver, reusable
Reduction Screw Driver, Tri-Flat
Seaspine Orthopedics Corporation
90-1242
In Commercial Distribution

  • 10889981182748 ()
90-1242

  • Surgical screwdriver, reusable
Reduction Screw Driver, Locking, Square Connect
Seaspine Orthopedics Corporation
90-1240
In Commercial Distribution

  • 10889981182724 ()
90-1240

  • Surgical screwdriver, reusable
Easy Release Shank Driver, Long
Seaspine Orthopedics Corporation
SR-0389
In Commercial Distribution

  • 10889981182700 ()
SR-0389

  • Orthopaedic implant driver
REDUCER MULTI-DRIVER
Seaspine Orthopedics Corporation
MM2-000342
In Commercial Distribution

  • 10889981182267 ()
MM2-000342

  • Orthopaedic implant driver
No Description
Biomet Orthopedics, LLC
405898
In Commercial Distribution

  • 00880304469662 ()
405898

  • Surgical screwdriver, reusable
SpinPlate Driver
Seaspine Orthopedics Corporation
SR-0421
In Commercial Distribution

  • 10889981180553 ()
SR-0421

  • Orthopaedic implant driver
LOCKING SET SCREW STARTER
Seaspine Orthopedics Corporation
MM2-000400
In Commercial Distribution

  • 10889981178383 ()
MM2-000400

  • Orthopaedic implant driver
FINAL DRIVER
Seaspine Orthopedics Corporation
MM2-000360
In Commercial Distribution

  • 10889981178345 ()
MM2-000360

  • Orthopaedic implant driver
REDUCER DRIVER
Seaspine Orthopedics Corporation
MM2-000340
In Commercial Distribution

  • 10889981178307 ()
MM2-000340

  • Orthopaedic implant driver
CD DRIVER
Seaspine Orthopedics Corporation
MM2-000220
In Commercial Distribution

  • 10889981178222 ()
MM2-000220

  • Orthopaedic implant driver
MIS NAVIGATION DRIVER
Seaspine Orthopedics Corporation
MM2-000190
In Commercial Distribution

  • 10889981178208 ()
MM2-000190

  • Orthopaedic implant driver
No Description
Biomet Orthopedics, LLC
231201340
In Commercial Distribution

  • 00880304805064 ()

  • 2.5MM
231201340

  • Surgical screwdriver, reusable
No Description
BIOMET SPINE LLC
730M0017
In Commercial Distribution

  • 00880304852761 ()
730M0017

  • Surgical screwdriver, reusable
No Description
BIOMET SPINE LLC
137M0016
In Commercial Distribution

  • 00880304851467 ()

  • Slap Hammer
137M0016

  • Orthopaedic implant driver
No Description
Biomet Orthopedics, LLC
14-448750
In Commercial Distribution

  • 00880304739758 ()
14-448750

  • Surgical drill guide, single-use
No Description
Biomet Orthopedics, LLC
110016964
In Commercial Distribution

  • 00880304692909 ()
110016964

  • Surgical screwdriver, reusable
VECTOR TAS DRIVER TIP 22MM - Qty 2
ORMCO CORPORATION
601-0012
In Commercial Distribution

  • 10889989000051 ()
  • 00889989000054 ()

  • 22mm Driver Tip Diameter


  • Orthodontic anchoring screw
VECTOR TAS DRIVER TIP 40MM - Qty 2
ORMCO CORPORATION
601-0011
In Commercial Distribution

  • 10889989000044 ()
  • 00889989000047 ()

  • 40mm Driver Tip Diameter


  • Orthodontic anchoring screw
4mm Driver
Seaspine Orthopedics Corporation
SR-0352
Not in Commercial Distribution

  • 10889987170398 ()
SR-0352

  • Orthopaedic implant driver
Cortical Screw Shank Driver, Long
Seaspine Orthopedics Corporation
MC2-003012
Not in Commercial Distribution

  • 10889987170114 ()
MC2-003012

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Cortical Screw Shank Driver, Short
Seaspine Orthopedics Corporation
MC2-003011
Not in Commercial Distribution

  • 10889987170107 ()
MC2-003011

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Cortical Screw Shank Driver
Seaspine Orthopedics Corporation
MC2-003010
Not in Commercial Distribution

  • 10889987170091 ()
MC2-003010

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Split Tip Mariner Tulip Cap Driver
Seaspine Orthopedics Corporation
SR-1081
In Commercial Distribution

  • 10889981310110 ()
SR-1081

  • Orthopaedic implant driver
Screw Shim Driver
Seaspine Orthopedics Corporation
SR-1054
In Commercial Distribution

  • 10889981309619 ()
SR-1054

  • Orthopaedic implant driver
Screw Driver, A/O Connect
Seaspine Orthopedics Corporation
SR-1070
In Commercial Distribution

  • 10889981309503 ()
SR-1070

  • Orthopaedic implant driver
T25 Driver, Non-Tapered
Seaspine Orthopedics Corporation
SR-1016
In Commercial Distribution

  • 10889981309282 ()
SR-1016

  • Orthopaedic implant driver
Uniaxial Stab and Grab Driver
Seaspine Orthopedics Corporation
SR-1059
In Commercial Distribution

  • 10889981309176 ()
SR-1059

  • Orthopaedic implant driver
Polyaxial Stab and Grab Driver
Seaspine Orthopedics Corporation
SR-1058
In Commercial Distribution

  • 10889981309169 ()
SR-1058

  • Orthopaedic implant driver
Shoreline 45 deg Flex Driver
Seaspine Orthopedics Corporation
SR-1048
In Commercial Distribution

  • 10889981308681 ()
SR-1048

  • Orthopaedic implant driver
Hex Driver, T30, Tri-Flat Connect
Seaspine Orthopedics Corporation
SR-1046
In Commercial Distribution

  • 10889981308520 ()
SR-1046

  • Orthopaedic implant driver
Winged Final Driver
Seaspine Orthopedics Corporation
SR-1021
In Commercial Distribution

  • 10889981308490 ()
SR-1021

  • Orthopaedic implant driver
Occipital Modular Driver, Short
Seaspine Orthopedics Corporation
SR-1028
In Commercial Distribution

  • 10889981308421 ()
SR-1028

  • Orthopaedic implant driver
Split Tip Hex Driver, 4mm
Seaspine Orthopedics Corporation
SR-0337
Not in Commercial Distribution

  • 10889987164434 ()
SR-0337

  • Orthopaedic implant driver
Straight Driver, Short
Seaspine Orthopedics Corporation
SR-1371
In Commercial Distribution

  • 10889981435196 ()
SR-1371

  • Orthopaedic implant driver
Lattus Offset Driver
Seaspine Orthopedics Corporation
SR-1354
In Commercial Distribution

  • 10889981403577 ()
SR-1354

  • Self-retaining surgical retractor, reusable
Angled Driver, Short, Retention Rod
Seaspine Orthopedics Corporation
SR-1324
In Commercial Distribution

  • 10889981365257 ()
SR-1324

  • Orthopaedic implant driver
Angled Driver, Retention Rod
Seaspine Orthopedics Corporation
SR-1271
In Commercial Distribution

  • 10889981333249 ()
SR-1271

  • Orthopaedic implant driver
Set Screw Starter
Seaspine Orthopedics Corporation
SR-1303
In Commercial Distribution

  • 10889981332655 ()
SR-1303

  • Orthopaedic implant driver
Adjustable Locking Screwdriver w/ Stryker-Hall End
Seaspine Orthopedics Corporation
SR-1293
In Commercial Distribution

  • 10889981331306 ()
SR-1293

  • Orthopaedic implant driver
Closed Polyaxial Screwdriver w/ Stryker-Hall End
Seaspine Orthopedics Corporation
SR-1292
In Commercial Distribution

  • 10889981331290 ()
SR-1292

  • Orthopaedic implant driver
Mariner Driver, Shortened w/o Spin Sleeve
Seaspine Orthopedics Corporation
SR-1287
In Commercial Distribution

  • 10889981331160 ()
SR-1287

  • Orthopaedic implant driver
Sleeve, MIS Locking Navigation Driver
Seaspine Orthopedics Corporation
SR-1183-20
In Commercial Distribution

  • 10889981326012 ()
SR-1183-20

  • Orthopaedic implantation sleeve, reusable
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