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 I/M Rod 8mm
Ortho Development Corporation
662-0121
In Commercial Distribution

  • 00822409063628 ()

  • Outer Diameter: 8 Millimeter


  • Osteotomy guide, reusable
Slim I/M Sleeve Adapter
Ortho Development Corporation
C-1756
In Commercial Distribution

  • 00822409114115 ()


  • Orthopaedic implant-instrument extension adaptor, reusable
Offset I/M Alignment Guide
Ortho Development Corporation
C-1731
In Commercial Distribution

  • 00822409110438 ()
C-1731

  • Osteotomy guide, reusable
Notched I/M Alignment Guide
Ortho Development Corporation
C-1715
In Commercial Distribution

  • 00822409107186 ()


  • Osteotomy guide, reusable
Ulnar Saw Guide Gen I
WRIGHT MEDICAL TECHNOLOGY, INC.
40100101
In Commercial Distribution

  • 00889797008631 ()
40100101

  • Osteotomy guide, reusable
Le Fort I plate left
Stryker Leibinger GmbH & Co. KG
92-11745
In Commercial Distribution

  • 07613327599916 ()

  • Bar Length: 5.0 Millimeter
  • Number of Screw Holes: 11.0 Holes
92-11745

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Le Fort I plate left
Stryker Leibinger GmbH & Co. KG
92-11744
In Commercial Distribution

  • 07613327599909 ()

  • Number of Screw Holes: 11.0 Holes
  • Bar Length: 4.0 Millimeter
92-11744

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Le Fort I plate right
Stryker Leibinger GmbH & Co. KG
92-12745
In Commercial Distribution

  • 07613327599893 ()

  • Number of Screw Holes: 11.0 Holes
  • Bar Length: 5.0 Millimeter
92-12745

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Le Fort I plate right
Stryker Leibinger GmbH & Co. KG
92-12744
In Commercial Distribution

  • 07613327599886 ()

  • Bar Length: 4.0 Millimeter
  • Number of Screw Holes: 11.0 Holes
92-12744

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Le Fort I plate left
Stryker Leibinger GmbH & Co. KG
92-11743
In Commercial Distribution

  • 07613327599855 ()

  • Number of Screw Holes: 11.0 Holes
  • Bar Length: 3.0 Millimeter
92-11743

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Le Fort I plate right
Stryker Leibinger GmbH & Co. KG
92-12743
In Commercial Distribution

  • 07613327599848 ()

  • Bar Length: 3.0 Millimeter
  • Number of Screw Holes: 11.0 Holes
92-12743

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Le Fort I plate left
Stryker Leibinger GmbH & Co. KG
92-11740
In Commercial Distribution

  • 07613327599817 ()

  • Bar Length: 0.0 Millimeter
  • Number of Screw Holes: 11.0 Holes
92-11740

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Le Fort I plate right
Stryker Leibinger GmbH & Co. KG
92-12740
In Commercial Distribution

  • 07613327599800 ()

  • Bar Length: 0.0 Millimeter
  • Number of Screw Holes: 11.0 Holes
92-12740

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
SALTO TALARIS ANATOMIC ANKLE I
Ascension Orthopedics, Inc.
YKAL06T
Not in Commercial Distribution

  • 10381780373957 ()


  • Joint prosthesis implantation kit, reusable
SALTO TALARIS ANATOMIC ANKLE I
Ascension Orthopedics, Inc.
YKAL05T
Not in Commercial Distribution

  • 10381780373940 ()


  • Joint prosthesis implantation kit, reusable
WET PVP I PREP TRAY
Cardinal Health 200, LLC
39-4980A
In Commercial Distribution

  • 50197106089673 ()
  • 10197106089675 ()
39-4980A

  • General surgical procedure kit, non-medicated, single-use
Lateral I/M Alignment Assembly
Stryker GmbH
933-0025
In Commercial Distribution

  • 00886385019031 ()


  • Orthopaedic implant aiming arm
NEO I V START TRAY
Cardinal Health 200, LLC
01-4474N
In Commercial Distribution

  • 50197106340330 ()
  • 10197106340332 ()
01-4474N

  • Vascular catheterization support/maintenance kit, non-medicated
I AND D VAGINAL PACK
Cardinal Health 200, LLC
08B7483A
In Commercial Distribution

  • 50195594774651 ()
  • 10195594774653 ()
08B7483A

  • Obstetrical/gynaecological surgical procedure kit, medicated
I R LUMBAR PUNCTURE PACK
Cardinal Health 200, LLC
SAN31LPN11
In Commercial Distribution

  • 50195594752819 ()
  • 10195594752811 ()
SAN31LPN11

  • Angiography kit
ANTHOLOGY BROACH HANDLE TRAY i
Smith & Nephew, Inc.
71365842
In Commercial Distribution

  • 00885556761526 ()
71365842

  • Instrument tray, reusable
ANTHOLOGY CORE INSTRUMENT TRAY i
Smith & Nephew, Inc.
71365841
In Commercial Distribution

  • 00885556761519 ()
71365841

  • Instrument tray, reusable
BROACH HANDLE STRIKE PLATE i
Smith & Nephew, Inc.
71365722
In Commercial Distribution

  • 00885556761281 ()
71365722

  • Orthopaedic implant impactor, reusable
ANTHOLOGY SOFT STEM INSERTER i
Smith & Nephew, Inc.
71365617
In Commercial Distribution

  • 00885556761250 ()
71365617

  • Orthopaedic inorganic implant inserter/extractor, reusable
ANTHOLOGY THREADED STEM INSERTER i
Smith & Nephew, Inc.
71365616
In Commercial Distribution

  • 00885556761243 ()
71365616

  • Orthopaedic inorganic implant inserter/extractor, reusable
ANTHOLOGY BROACH i SIZE 14
Smith & Nephew, Inc.
71365314
In Commercial Distribution

  • 00885556761052 ()
71365314

  • Orthopaedic broach
ANTHOLOGY BROACH i SIZE 13
Smith & Nephew, Inc.
71365313
In Commercial Distribution

  • 00885556761045 ()
71365313

  • Orthopaedic broach
ANTHOLOGY BROACH i SIZE 12
Smith & Nephew, Inc.
71365312
In Commercial Distribution

  • 00885556761038 ()
71365312

  • Orthopaedic broach
ANTHOLOGY BROACH i SIZE 11
Smith & Nephew, Inc.
71365311
In Commercial Distribution

  • 00885556761021 ()
71365311

  • Orthopaedic broach
ANTHOLOGY BROACH i SIZE 10
Smith & Nephew, Inc.
71365310
In Commercial Distribution

  • 00885556761014 ()
71365310

  • Orthopaedic broach
ANTHOLOGY BROACH i SIZE 9
Smith & Nephew, Inc.
71365309
In Commercial Distribution

  • 00885556761007 ()
71365309

  • Orthopaedic broach
ANTHOLOGY BROACH i SIZE 8
Smith & Nephew, Inc.
71365308
In Commercial Distribution

  • 00885556760994 ()
71365308

  • Orthopaedic broach
ANTHOLOGY BROACH i SIZE 7
Smith & Nephew, Inc.
71365307
In Commercial Distribution

  • 00885556760987 ()
71365307

  • Orthopaedic broach
ANTHOLOGY BROACH i SIZE 6
Smith & Nephew, Inc.
71365306
In Commercial Distribution

  • 00885556760970 ()
71365306

  • Orthopaedic broach
ANTHOLOGY BROACH i SIZE 5
Smith & Nephew, Inc.
71365305
In Commercial Distribution

  • 00885556760963 ()
71365305

  • Orthopaedic broach
ANTHOLOGY BROACH i SIZE 4
Smith & Nephew, Inc.
71365304
In Commercial Distribution

  • 00885556760956 ()
71365304

  • Orthopaedic broach
ANTHOLOGY BROACH i SIZE 3
Smith & Nephew, Inc.
71365303
In Commercial Distribution

  • 00885556760949 ()
71365303

  • Orthopaedic broach
ANTHOLOGY BROACH i SIZE 2
Smith & Nephew, Inc.
71365302
In Commercial Distribution

  • 00885556760932 ()
71365302

  • Orthopaedic broach
ANTHOLOGY BROACH i SIZE 1
Smith & Nephew, Inc.
71365301
In Commercial Distribution

  • 00885556760925 ()
71365301

  • Orthopaedic broach
SINGLE OFFSET BROACH HANDLE i
Smith & Nephew, Inc.
71365728
In Commercial Distribution

  • 00885556760871 ()
71365728

  • Surgical instrument handle, non-torque-limiting
I R LUMBAR PUNCTURE PACK
Cardinal Health 200, LLC
SAN31LPNWE
In Commercial Distribution

  • 50195594780089 ()
  • 10195594780081 ()
SAN31LPNWE

  • Angiography kit
WET PVP I PREP TRAY
Cardinal Health 200, LLC
39-4980C
In Commercial Distribution

  • 50197106259106 ()
  • 10197106259108 ()
39-4980C

  • General surgical procedure kit, non-medicated, single-use
Endoscopic Seal, Type I (adapter)
Well Lead Medical Co.,Ltd
U04D020110
In Commercial Distribution

  • 16944932785127 ()
  • 06944932785120 ()
  • 26944932785124 ()


  • Endoscope working-channel valve, single-use
STELLARIS I/A HANDPIECE SYSTEM
Bausch & Lomb Incorporated
BL3160
In Commercial Distribution

  • 00757770483488 ()
BL3160

  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable
HANDPIECE I/A 17GA ANGLED
Bausch & Lomb Incorporated
MVS 1063C
In Commercial Distribution

  • 00757770432387 ()
MVS 1063C

  • Ophthalmic surgical irrigation/infusion/aspiration handle, reusable
NEO I V START TRAY
Cardinal Health 200, LLC
01-4474L
In Commercial Distribution

  • 50197106104949 ()
  • 10197106104941 ()
01-4474L

  • Vascular catheterization support/maintenance kit, non-medicated
NEO I V START TRAY
Cardinal Health 200, LLC
01-4474M
In Commercial Distribution

  • 50197106150717 ()
  • 10197106150719 ()
01-4474M

  • Vascular catheterization support/maintenance kit, non-medicated
CUSTOM PACK CB9N30R1 SUPPORT I
MEDTRONIC, INC.
CB9N30R1
In Commercial Distribution

  • 00763000273811 ()


  • Cardiopulmonary bypass system blood tubing set
KIT, I V START, NMH
Cardinal Health 200, LLC
IVSMV00423
In Commercial Distribution

  • 50197106063543 ()
  • 10197106063545 ()
IVSMV00423

  • General surgical procedure kit, medicated
MAJOR EXTREMITY PK I STANDARD
DEROYAL INDUSTRIES, INC.
89-5072
In Commercial Distribution

  • 50749756889969 ()
  • 00749756889964 ()
89-5072

  • General surgical procedure kit, non-medicated, single-use
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