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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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U2™ Knee - 04719872177531

Gap gauge, 9/11mm
UNITED ORTHOPEDIC CORP.
9404-7009
In Commercial Distribution

  • 04719872177531 ()

  • 9/11mm
9404-7009

  • Surgical implant template, reusable

U2™ Knee - 04719872174899

Femoral IM rod, 9×400mm
UNITED ORTHOPEDIC CORP.
9303-3210
In Commercial Distribution

  • 04719872174899 ()

  • 9×400mm
9303-3210

  • Orthopaedic implant/instrument assembling device

U2™ Knee - 04719872174554

Femoral IM alignment guide, 9°, right
UNITED ORTHOPEDIC CORP.
9303-2349
In Commercial Distribution

  • 04719872174554 ()

  • 9°, right
9303-2349

  • Orthopaedic fixation implant alignment tool

U2™ Knee - 04719872174493

Femoral IM alignment guide, 9°, left
UNITED ORTHOPEDIC CORP.
9303-2339
In Commercial Distribution

  • 04719872174493 ()

  • 9°, left
9303-2339

  • Orthopaedic fixation implant alignment tool

U2™ Knee - 04719872174400

Femoral IM alignment guide , 9°, left
UNITED ORTHOPEDIC CORP.
9303-2319
In Commercial Distribution

  • 04719872174400 ()

  • 9°, left
9303-2319

  • Orthopaedic fixation implant alignment tool

U2™ Knee - 04719872174349

Femoral IM alignment guide , 9°, right
UNITED ORTHOPEDIC CORP.
9303-2309
In Commercial Distribution

  • 04719872174349 ()

  • 9°, right
9303-2309

  • Orthopaedic fixation implant alignment tool

UTF™ Stem - 04719872167525

UTF Broach, reduced, #9
UNITED ORTHOPEDIC CORP.
9106-6309
In Commercial Distribution

  • 04719872167525 ()

  • reduced, #9
9106-6309

  • Orthopaedic broach

CYLOX ST - 04047844128015

An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery.
SIGNUS Medizintechnik GmbH
Drill guide
In Commercial Distribution

  • 04047844128015 ()

  • Cage 9
CZ0003-09

  • Orthopaedic surgical procedure kit, non-medicated, reusable

implaFit® trial neck K12/14 lat. stem - 04048844525798

No Description
implantcast GmbH
80084089
In Commercial Distribution

  • 04048844525798 ()

  • 8+9


  • Femoral head prosthesis trial

implaFit® trial neck K12/14 std. stem - 04048844525583

No Description
implantcast GmbH
80083089
In Commercial Distribution

  • 04048844525583 ()

  • 8+9


  • Femoral head prosthesis trial

MOBIS - 04047844045190

An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery.
SIGNUS Medizintechnik GmbH
Graft loading platform
In Commercial Distribution

  • 04047844045190 ()

  • 9/11mm
B026AH

  • Orthopaedic surgical procedure kit, non-medicated, reusable

ATHLET - 04047844044704

An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery.
SIGNUS Medizintechnik GmbH
Inserter plate
In Commercial Distribution

  • 04047844044704 ()

  • 8/9
AT0007

  • Orthopaedic surgical procedure kit, non-medicated, reusable

BethaLoc® - 04048844239480

stem cementless lateralized HA
implantcast GmbH
87001029
In Commercial Distribution

  • 04048844239480 ()

  • sz. 9


  • Press-fit femoral stem prosthesis

BethaLoc® - 04048844239459

stem cementless standard HA
implantcast GmbH
87001009
In Commercial Distribution

  • 04048844239459 ()

  • sz. 9


  • Press-fit femoral stem prosthesis

Actinia® - 04048844153410

hip stem with collar cementless standard
implantcast GmbH
80040409
In Commercial Distribution

  • 04048844153410 ()

  • sz. 9


  • Press-fit femoral stem prosthesis

Actinia® - 04048844153359

hip stem with collar cementless lateralized
implantcast GmbH
80040509
In Commercial Distribution

  • 04048844153359 ()

  • sz. 9


  • Press-fit femoral stem prosthesis

Actinia® - 04048844152802

hip stem cementless standard
implantcast GmbH
80040009
In Commercial Distribution

  • 04048844152802 ()

  • sz. 9


  • Press-fit femoral stem prosthesis

Actinia® - 04048844152741

hip stem cementless lateralized
implantcast GmbH
80040109
In Commercial Distribution

  • 04048844152741 ()

  • sz. 9


  • Press-fit femoral stem prosthesis

Uni FB joint gap check resection - 04048844544560

No Description
implantcast GmbH
42160386
In Commercial Distribution

  • 04048844544560 ()

  • -9/-10mm


  • Abdominal/ENT/orthopaedic surgical probe, reusable

TUMARK Flex - 04250195602213

No Description
SOMATEX Medical Technologies GmbH
271576
Not in Commercial Distribution

  • 04250195604682 ()
  • 04250195602213 ()

  • 9 Gauge
271576

  • Radiological image marker, implantable

ACRYSOF® - 00380652249676

AcrySof(R) IQ TORIC ASTIGMATISM IOL, SINGLE-PIECE ACRYLIC FOLDABLE LENS, UV WITH BLUE LIGHTFILTER, 13.0mm LENGTH, 6.0mm BICONVEX TORICASPHERIC OPTIC, 1.50 D CYLINDER.
Alcon Laboratories, Inc.
SN6AT3
In Commercial Distribution

  • 00380652249676 ()

  • Diopter 9
SN6AT3.090

  • Posterior-chamber intraocular lens, pseudophakic

ACRYSOF® IQ RESTOR® - 00380652249591

AcrySof(R) IQ ReSTOR(R) MULTIFOCAL IOL, SINGLE-PIECE ACRYLIC FOLDABLE LENS, UV WITH BLUE LIGHTFILTER, 13.0mm LENGTH, 6.0mm APODIZEDDIFFRACTIVE ASPHERIC OPTIC.
Alcon Laboratories, Inc.
SN6AD1
Not in Commercial Distribution

  • 00380652249591 ()

  • Diopter 9


  • Posterior-chamber intraocular lens, pseudophakic

ACRYSOF® IQ RESTOR® - 00380652249515

AcrySof(R) IQ ReSTOR(R) MULTIFOCAL IOL, SINGLE-PIECE ACRYLIC FOLDABLE LENS, UV WITH BLUE LIGHTFILTER, 13.0mm LENGTH, 6.0mm APODIZEDDIFFRACTIVE ASPHERIC OPTIC.
Alcon Laboratories, Inc.
SN6AD1
Not in Commercial Distribution

  • 00380652249515 ()

  • Diopter 9


  • Posterior-chamber intraocular lens, pseudophakic

ACRYSOF® ACRYSERT® - 00380652248990

AcrySof(R) IQ ASPHERIC IOL, SP ACRYLIC FOLDABLELENS, w/AcrySert(R) DELIVERY SYSTEM, UV w/BLUELIGHT FILTER, 13.0mm LENGTH, 6.0mm ANTERIORASYMMETRIC BICONVEX OPTIC, PLANAR HAPTICS.
Alcon Laboratories, Inc.
SN6CWS
Not in Commercial Distribution

  • 00380652248990 ()

  • Diopter 9
SN6CWS.090

  • Posterior-chamber intraocular lens, pseudophakic

Alcon Single-Piece PMMA Slant - 00380650702289

SINGLE-PIECE PMMA STERILE PCL (IOL/PC),12.5mm LENGTH, 6.0mm BICONVEX OPTIC,5-DEGREE "SLANT"(TM*) HAPTICS. *REG. U.S. PAT. & TM OFF.
Alcon Laboratories, Inc.
MZ60BD
Not in Commercial Distribution

  • 00380650702289 ()

  • Diopter 9
MZ60BD.090

  • Posterior-chamber intraocular lens, pseudophakic

Multiflex - 00380650701060

MULTIFLEX(TM*)III SINGLE-PIECE PMMASTERILE ACL (IOL/AC), 12.5mm LENGTH, 5.5mmCONVEXOPLANO OPTIC, 0.5mm VAULTED HAPTICS. *REG. U.S. PAT. & TM OFF.
Alcon Laboratories, Inc.
MTA3U0
In Commercial Distribution

  • 00380650701060 ()

  • Diopter 9
MTA3U0.090

  • Anterior-chamber intraocular lens, pseudophakic

ACRYSOF® Monoflex® - 00380650698315

AcrySof(R) SOFT ACRYLIC MULTIPIECE STERILEPCL (IOL/PC), 13.0mm LENGTH, 6.5mm BICONVEXOPTIC, 10-DEGREE Monoflex(TM*) HAPTICS. *REG. U.S. PAT. & TM OFF.
Alcon Laboratories, Inc.
MA50BM
In Commercial Distribution

  • 00380650698315 ()

  • Diopter 9
MA50BM.090

  • Posterior-chamber intraocular lens, pseudophakic

ACRYSOF® - 00380650130082

AcrySof(R) Natural SINGLE-PIECE ACRYLICFOLDABLE IOL, UV WITH BLUE LIGHT FILTER,POSTERIOR CHAMBER LENS (IOL/PC), 13.0mm LENGTH,6.0mm BICONVEX OPTIC, PLANAR HAPTICS.
Alcon Laboratories, Inc.
SN60AT
In Commercial Distribution

  • 00380650130082 ()

  • Diopter 9
SN60AT.090

  • Posterior-chamber intraocular lens, pseudophakic

Made-To-Order - 00846832097012

AFR Short Prox Body Trial
TORNIER, INC.
9027385
In Commercial Distribution

  • 00846832097012 ()

  • Size: 9
9027385

  • Orthopaedic fixation plate tensioner

Made-To-Order - 00846832095926

Revive Proximal Broach
TORNIER, INC.
9027272
In Commercial Distribution

  • 00846832095926 ()

  • Size: 9
9027272

  • Orthopaedic fixation plate tensioner

Tornier Perform Humeral System - 00846832086023

Fracture Rasp
TORNIER, INC.
IFX209
In Commercial Distribution

  • 00846832086023 ()

  • Size: 9
  • Length: 130 Millimeter
IFX209

  • Orthopaedic prosthesis implantation positioning instrument, reusable

Ascend - 00846832024223

HUMERAL DISTAL TRIAL
TORNIER, INC.
SH070209
In Commercial Distribution

  • 00846832024223 ()

  • Size 9
SH070209

  • Humeral stem prosthesis trial, reusable

Ascend - 00846832024148

MONOLITHIC BROACH
TORNIER, INC.
SH070109
In Commercial Distribution

  • 00846832024148 ()

  • Size 9
SH070109

  • Orthopaedic broach

RESTORIS - 00848486008123

Tapered Femoral Stem, Ext Offset Neck, 12/14 Taper
MAKO SURGICAL CORP.
186004-09
In Commercial Distribution

  • 00848486008123 ()

  • Size: 9
186004-09

  • Press-fit femoral stem prosthesis

RESTORIS - 00848486008116

Tapered Femoral Stem, Standard Neck, 12/14 Taper
MAKO SURGICAL CORP.
186003-09
In Commercial Distribution

  • 00848486008116 ()

  • Size: 9
186003-09

  • Press-fit femoral stem prosthesis

Tornier Perform Humeral System - 00846832086139

Fracture Rasp Metaphysis
TORNIER, INC.
IFX309
In Commercial Distribution

  • 00846832086139 ()

  • Size: 9
IFX309

  • Orthopaedic prosthesis implantation positioning instrument, reusable

Tornier Perform Humeral System - 00846832086016

Fracture Rasp
TORNIER, INC.
IFX20990
In Commercial Distribution

  • 00846832086016 ()

  • Length: 90 Millimeter
  • Size: 9
IFX20990

  • Orthopaedic prosthesis implantation positioning instrument, reusable

ACRYSOF® - 00380652332446

AcrySof(R) ASPHERIC IOL, SINGLE-PIECE ACRYLICFOLDABLE POSTERIOR CHAMBER LENS,UV-ABSORBING, 13.0mm LENGTH, 6.0mm ANTERIORASYMMETRIC BICONVEX OPTIC, PLANAR HAPTICS.
Alcon Laboratories, Inc.
SA60WF
In Commercial Distribution

  • 00380652332446 ()

  • Diopter 9
SA60WF.090

  • Posterior-chamber intraocular lens, pseudophakic

ACRYSOF® RESTOR® - 00380652307529

AcrySof(R) IQ ReSTOR(R) MULTIFOCAL IOL, SINGLE-PIECE ACRYLIC FOLDABLE LENS, UV WITH BLUE LIGHTFILTER, 13.0mm LENGTH, 6.0mm APODIZEDDIFFRACTIVE ASPHERIC OPTIC.
Alcon Laboratories, Inc.
SV25T0
Not in Commercial Distribution

  • 00380652307529 ()

  • Diopter 9


  • Posterior-chamber intraocular lens, pseudophakic

ACRYSOF® - 00380652279406

AcrySof(R) IQ TORIC ASTIGMATISM IOL, SINGLE-PIECE ACRYLIC FOLDABLE LENS, UV WITH BLUE LIGHTFILTER, 13.0mm LENGTH, 6.0mm BICONVEX TORICASPHERIC OPTIC, 6.00 D CYLINDER.
Alcon Laboratories, Inc.
SN6AT9
Not in Commercial Distribution

  • 00380652279406 ()

  • Diopter 9
SN6AT9U090

  • Posterior-chamber intraocular lens, pseudophakic

ACRYSOF® - 00380652277822

AcrySof(R) IQ TORIC ASTIGMATISM IOL, SINGLE-PIECE ACRYLIC FOLDABLE LENS, UV WITH BLUE LIGHTFILTER, 13.0mm LENGTH, 6.0mm BICONVEX TORICASPHERIC OPTIC, 5.25 D CYLINDER.
Alcon Laboratories, Inc.
SN6AT8
Not in Commercial Distribution

  • 00380652277822 ()

  • Diopter 9
SN6AT8U090

  • Posterior-chamber intraocular lens, pseudophakic

ACRYSOF® - 00380652276238

AcrySof(R) IQ TORIC ASTIGMATISM IOL, SINGLE-PIECE ACRYLIC FOLDABLE LENS, UV WITH BLUE LIGHTFILTER, 13.0mm LENGTH, 6.0mm BICONVEX TORICASPHERIC OPTIC, 4.50 D CYLINDER.
Alcon Laboratories, Inc.
SN6AT7
Not in Commercial Distribution

  • 00380652276238 ()

  • Diopter 9
SN6AT7U090

  • Posterior-chamber intraocular lens, pseudophakic

ACRYSOF® - 00380652274647

AcrySof(R) IQ TORIC ASTIGMATISM IOL, SINGLE-PIECE ACRYLIC FOLDABLE LENS, UV WITH BLUE LIGHTFILTER, 13.0mm LENGTH, 6.0mm BICONVEX TORICASPHERIC OPTIC, 3.75 D CYLINDER.
Alcon Laboratories, Inc.
SN6AT6
Not in Commercial Distribution

  • 00380652274647 ()

  • Diopter 9
SN6AT6U090

  • Posterior-chamber intraocular lens, pseudophakic

ACRYSOF ULTRASERT - 00380652358057

AcrySof(R) IQ ASPHERIC IOL SP ACRYLIC FOLDABLELENS wUltraSert(TM) DELIVERY SYSTEM UV wBLUE LIGHT FILTER. 13.0mm LENGTH 6.0mm ANTERIORASYMMETRIC BICONVEX OPTIC PLANAR HAPTICS.
Alcon Laboratories, Inc.
AU00T0
In Commercial Distribution

  • 00380652358057 ()

  • Diopter 9
AU00T0.090

  • Posterior-chamber intraocular lens, pseudophakic

ACRYSOF, IQ RESTOR - 00380652270403

Acrysof IQ ReStor Multifocal Toric IOL, STERILE UV and Blue Light Filtering Acrylic Foldable; Apodized Diffractive Aspheric Multifocal Toric Posterior Chamber Intraocular Lens; IOL Cylinder Power 2.31
Alcon Laboratories, Inc.
SND1T4
Not in Commercial Distribution

  • 00380652270403 ()

  • Diopter 9
SND1T4U090

  • Posterior-chamber intraocular lens, pseudophakic

ACRYSOF® IQ RESTOR ® Monoflex® - 00380652262835

AcrySof(R) IQ ReSTOR(R) APODIZED DIFFRACTIVEMULTIPIECE STERILE PCL(IOL/PC) 13.0mm LENGTH 6.0mm OPTIC 10-DEGREE Monoflex(TM*) HAPTICS.*REG. U.S. PAT. & TM OFF.
Alcon Laboratories, Inc.
MN6AD1
In Commercial Distribution

  • 00380652262835 ()

  • Diopter 9


  • Posterior-chamber intraocular lens, pseudophakic

ACRYSOF® - 00380652250771

AcrySof(R) IQ TORIC ASTIGMATISM IOL, SINGLE-PIECE ACRYLIC FOLDABLE LENS, UV WITH BLUE LIGHTFILTER, 13.0mm LENGTH, 6.0mm BICONVEX TORICASPHERIC OPTIC, 3.00 D CYLINDER.
Alcon Laboratories, Inc.
SN6AT5
In Commercial Distribution

  • 00380652250771 ()

  • Diopter 9
SN6AT5.090

  • Posterior-chamber intraocular lens, pseudophakic

ACRYSOF® - 00380652250207

AcrySof(R) IQ TORIC ASTIGMATISM IOL, SINGLE-PIECE ACRYLIC FOLDABLE LENS, UV WITH BLUE LIGHTFILTER, 13.0mm LENGTH, 6.0mm BICONVEX TORICASPHERIC OPTIC, 2.25 D CYLINDER.
Alcon Laboratories, Inc.
SN6AT4
In Commercial Distribution

  • 00380652250207 ()

  • Diopter 9
SN6AT4.090

  • Posterior-chamber intraocular lens, pseudophakic

AcrySof® ACRYSERT® - 00380655097243

AcrySof(R) IQ ASPHERIC Natural SP IOL WITHTHE AcrySert(R) DELIVERY SYSTEM, UV WITH BLUELIGHT FILTER, 13.0mm LENGTH, 6.0mm ANTERIORASYMMETRIC BICONVEX OPTIC, PLANAR HAPTICS.
Alcon Laboratories, Inc.
SN60WS
Not in Commercial Distribution

  • 00380655097243 ()

  • Diopter 9
SN60WS.090

  • Posterior-chamber intraocular lens, pseudophakic

ACRYSOF® - 00380655095591

AcrySof(R) IQ ASPHERIC Natural IOL, SINGLE-PIECE ACRYLIC FOLDABLE PCL, UV WITH BLUE LIGHTFILTER, 13.0mm LENGTH, 6.0mm ANTERIORASYMMETRIC BICONVEX OPTIC, PLANAR HAPTICS.
Alcon Laboratories, Inc.
SN60WF
In Commercial Distribution

  • 00380655095591 ()

  • Diopter 9
SN60WF.090

  • Posterior-chamber intraocular lens, pseudophakic
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