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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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Novation Element - 10885862249265

BROACH, NOVATION ELEMENT, SIZE 9
Exactech, Inc.
165-10-09
In Commercial Distribution

  • 10885862249265 ()

  • SIZE 9
165-10-09

  • Orthopaedic broach

Novation - 10885862239662

TEMPLATE, STEM, SIZE 9
Exactech, Inc.
161-95-50-09
In Commercial Distribution

  • 10885862239662 ()

  • SIZE 9
161-95-50-09

  • Surgical implant template, reusable

Novation - 10885862239488

TEMPLATE, STEM, SIZE 9
Exactech, Inc.
161-95-20-09
In Commercial Distribution

  • 10885862239488 ()

  • SIZE 9
161-95-20-09

  • Surgical implant template, reusable

Novation Element - 10885862204127

NV ELEM RO NT X/O SZ 9 NECK TRIAL
Exactech, Inc.
165-12-09
In Commercial Distribution

  • 10885862204127 ()

  • SIZE 9
165-12-09

  • Femoral stem prosthesis trial

Novation Element - 10885862204066

NV ELEM RO NT S/O SZ 9 NECK TRIAL
Exactech, Inc.
165-11-09
In Commercial Distribution

  • 10885862204066 ()

  • SIZE 9
165-11-09

  • Femoral stem 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

Vantage - 10885862546333

FCT GAP CHECK TL SZ 1-2
Exactech, Inc.
351-10-21
In Commercial Distribution

  • 10885862546333 ()

  • SIZE 9
351-10-21

  • Ankle prosthesis trial, reusable

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

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® - 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® - 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

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, 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® - 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® 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® 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

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

TUMARK Flex - 04250195602213

No Description
SOMATEX Medical Technologies GmbH
271576
Not in Commercial Distribution

  • 04250195604682 ()
  • 04250195602213 ()

  • 9 Gauge
271576

  • Radiological image marker, implantable

Multiflex - 00380652535670

MULTIFLEX™*III SINGLE-PIECE PMMA STERILE ACL (IOL/AC), 13.0mm LENGTH, 5.5mm CONVEXOPLANO OPTIC, 0.5mm VAULTED HAPTICS. *REG. U.S. PAT. & TM OFF.
Alcon Laboratories, Inc.
MTA4U0
In Commercial Distribution

  • 00380652535670 ()

  • Diopter 9
MTA4U0.090

  • Anterior-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® - 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

Uni FB joint gap check resection - 04048844544560

No Description
implantcast GmbH
42160386
In Commercial Distribution

  • 04048844544560 ()

  • -9/-10mm


  • Abdominal/ENT/orthopaedic surgical probe, 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

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

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

ACRYSOF® Monoflex® - 00380655094891

AcrySof(R) Natural ACRYLIC FOLDABLE IOL W/BLUELIGHT FILTER, PCL(IOL/PC), 13.0mm LENGTH, 6.0mmANTERIOR ASYMMETRIC BICONVEX OPTIC, 10-DEGREEMonoflex(TM*) HAPTICS. *REG. US PAT & TM OFF.
Alcon Laboratories, Inc.
MN60AC
In Commercial Distribution

  • 00380655094891 ()

  • Diopter 9
MN60AC.090

  • Posterior-chamber intraocular lens, pseudophakic

ACRYSOF® - 00380652555586

AcrySof(R) SINGLE-PIECE ACRYLIC FOLDABLE IOL,UV-ABSORBING POSTERIOR CHAMBER LENS (IOL/PC),13.0mm LENGTH, 6.0mm BICONVEX OPTIC, PLANARHAPTICS.
Alcon Laboratories, Inc.
SA60AT
In Commercial Distribution

  • 00380652555586 ()

  • Diopter 9
SA60AT.090

  • Posterior-chamber intraocular lens, pseudophakic

ACRYSOF® Monoflex® - 00380652552301

AcrySof(R) SOFT ACRYLIC MULTIPIECE STERILEPCL(IOL/PC), 13.0mm LENGTH, 6.0mm ANTERIORASYMMETRIC BICONVEX OPTIC, Monoflex(TM*)10-DEGREE HAPTICS. *REG. U.S. PAT. & TM OFF.
Alcon Laboratories, Inc.
MA60AC
In Commercial Distribution

  • 00380652552301 ()

  • Diopter 9
MA60AC.090

  • Posterior-chamber intraocular lens, pseudophakic

Alcon Single-Piece PMMA Slant - 00380652539753

SINGLE-PIECE PMMA STERILE PCL (IOL/PC),12.5mm LENGTH, 6.0mm PLANO-CONCAVE OPTIC,5-DEGREE "SLANT"(TM*) HAPTICS. *REG. U.S. PAT. & TM OFF.
Alcon Laboratories, Inc.
MZ60PD
Not in Commercial Distribution

  • 00380652539753 ()

  • Diopter -9
MZ60PDN090

  • Posterior-chamber intraocular lens, pseudophakic

Multiflex - 00380652536165

MULTIFLEX(TM*)III SINGLE-PIECE PMMASTERILE ACL (IOL/AC), 13.5mm LENGTH, 5.5mmCONVEXOPLANO OPTIC, 0.5mm VAULTED HAPTICS. *REG. U.S. PAT. & TM OFF.
Alcon Laboratories, Inc.
MTA5U0
In Commercial Distribution

  • 00380652536165 ()

  • Diopter 9
MTA5U0.090

  • Anterior-chamber intraocular lens, pseudophakic

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

Oxford Uni Knee System - 05019279400966

No Description
Biomet Uk Ltd
32-422819
In Commercial Distribution

  • 05019279400966 ()

  • Size 9
32-422819

  • Abdominal/ENT/orthopaedic surgical probe, reusable

Oxford Uni Knee System - 05019279400744

No Description
Biomet Uk Ltd
32-422814
In Commercial Distribution

  • 05019279400744 ()

  • Size 9
32-422814

  • Abdominal/ENT/orthopaedic surgical probe, reusable
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