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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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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® - 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

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

TUMARK Flex - 04250195602213

No Description
SOMATEX Medical Technologies GmbH
271576
Not in Commercial Distribution

  • 04250195604682 ()
  • 04250195602213 ()

  • 9 Gauge
271576

  • Radiological image marker, implantable

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

Oxford Uni Knee System - 05019279400553

No Description
Biomet Uk Ltd
32-422809
In Commercial Distribution

  • 05019279400553 ()

  • Size 9
32-422809

  • Abdominal/ENT/orthopaedic surgical probe, reusable

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

Paragon - 09340499024806

Paragon Distal Broach Size 9 - Male (Omni)
GLOBAL MANUFACTURING TECHNOLOGY PTY LIMITED
GM08001-349-09
In Commercial Distribution

  • 09340499024806 ()

  • Size 9
GM08001-349-09

  • Orthopaedic broach

Paragon - 09340499024608

Paragon Broach, Size 9 - Male (OMNI)
GLOBAL MANUFACTURING TECHNOLOGY PTY LIMITED
GM08001-321-09
In Commercial Distribution

  • 09340499024608 ()

  • Size 9
GM08001-321-09

  • Orthopaedic broach

BioPlex 2200 - 00847865010603

Celiac IgG Calibrator Set,
BIO-RAD LABORATORIES, INC.
6632200
In Commercial Distribution

  • 00847865010603 ()

  • Total Volume: 0.5 Milliliter
  • 9 Vials
6632200

  • Multiple Coeliac disease-associated antibody IVD, calibrator

BioPlex 2200 - 00847865010597

Celiac IgA Calibrator Set
BIO-RAD LABORATORIES, INC.
6632300
In Commercial Distribution

  • 00847865010597 ()

  • 9 Vials
  • Total Volume: 0.5 Milliliter
6632300

  • Multiple Coeliac disease-associated antibody IVD, calibrator

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

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

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

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® - 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® - 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® - 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® - 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 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

INSTRUMENT - 07613327330649

SPECIALTY SCORPIO SERIES 7000 FEMORAL CUTTING BLOCK
Howmedica Osteonics Corp.
I-K2885KF09
In Commercial Distribution

  • 07613327330649 ()

  • Size: 9
I-K2885KF09

  • Orthopaedic prosthesis implantation positioning instrument, reusable

INSTRUMENT - 07613327329230

SPECIALTY SCORPIO 3-IN-1 CUTTING BLOCK
Howmedica Osteonics Corp.
I-K3114KF09
In Commercial Distribution

  • 07613327329230 ()

  • Size: 9
I-K3114KF09

  • Orthopaedic prosthesis implantation positioning instrument, reusable

INSTRUMENT - 07613327325935

SPECIALTY SCORPIO SERIES 7000 TIBIAL TRAY TRIAL
Howmedica Osteonics Corp.
I-K2041KT09
In Commercial Distribution

  • 07613327325935 ()

  • Size: 9
I-K2041KT09

  • Knee tibia prosthesis trial, reusable

INSTRUMENT - 07613327325492

SPECIALTY SCORPIO PATELLA RESECTION GUARD
Howmedica Osteonics Corp.
I-K1774KP09
In Commercial Distribution

  • 07613327325492 ()

  • Size: 9
I-K1774KP09

  • Orthopaedic prosthesis implantation positioning instrument, reusable

INSTRUMENT - 07613327325423

SPECIALTY SCORPIO MIS 4-IN-1 RESECTION BLOCK
Howmedica Osteonics Corp.
I-K1757KF09
In Commercial Distribution

  • 07613327325423 ()

  • Size: 9
I-K1757KF09

  • Orthopaedic prosthesis implantation positioning instrument, reusable

INSTRUMENT - 07613327325089

SPECIALTY SCORPIO PATELLA DRILL GUIDE
Howmedica Osteonics Corp.
I-K0580PT09
In Commercial Distribution

  • 07613327325089 ()

  • Size: 9
I-K0580PT09

  • Surgical drill guide, reusable

INSTRUMENT - 07613327316995

SPECIALTY SCORPIO ROTHMAN-STYLE TIBIAL BASEPLATE
Howmedica Osteonics Corp.
I-K0598BP09
In Commercial Distribution

  • 07613327316995 ()

  • Size: 9
I-K0598BP09

  • Surgical implant template, reusable

INSTRUMENT - 07613327311808

Specialty Accolade II Broach Trial
Howmedica Osteonics Corp.
I-H1862HB09
In Commercial Distribution

  • 07613327311808 ()

  • Size: 9
I-H1862HB09

  • Orthopaedic broach

INSTRUMENT - 07613327310610

SPECIALTY SCORPIO 4 IN 1 AR CUTTING BLOCK
Howmedica Osteonics Corp.
I-K0905KF09
In Commercial Distribution

  • 07613327310610 ()

  • Size: 9
I-K0905KF09

  • Orthopaedic prosthesis implantation positioning instrument, reusable

INSTRUMENT - 07613327310429

SPECIALTY ACCOLADE II DUAL INCISION BROACH-HANDLE
Howmedica Osteonics Corp.
I-H1855BH09
In Commercial Distribution

  • 07613327310429 ()

  • Size: 9
I-H1855BH09

  • Orthopaedic broach

INSTRUMENT - 07613327308457

SPECIALTY SCORPIO NRG PR FEMORAL 4:1 CUTTING BLOCK
Howmedica Osteonics Corp.
I-K3138KF09
In Commercial Distribution

  • 07613327308457 ()

  • Size: 9
I-K3138KF09

  • Orthopaedic prosthesis implantation positioning instrument, reusable

DISTRACTION, INTERNAL - 00888118082121

PROTECTION SLEEVE, RIEDIGER, SOFT TISSUE, TI-6AL-4V
KLS-Martin L.P.
51-562-09-09
Not in Commercial Distribution

  • 00888118082121 ()

  • 9 MM


  • Implantable craniofacial bone distractor
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