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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® IQ RESTOR® - 00380652241762

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

  • 00380652241762 ()

  • Diopter 24


  • Posterior-chamber intraocular lens, pseudophakic

ACRYSOF® IQ RESTOR® - 00380652241311

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

  • 00380652241311 ()

  • Diopter 24


  • Posterior-chamber intraocular lens, pseudophakic

Alcon Single-Piece PMMA Slant - 00380650702586

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

  • 00380650702586 ()

  • Diopter 24
MZ60BD.240

  • Posterior-chamber intraocular lens, pseudophakic

RINGLOC + INSTRUMENTATION - 05019279415328

No Description
Biomet Uk Ltd
31-400624
In Commercial Distribution

  • 05019279415328 ()

  • SIZE 24
31-400624

  • Orthopaedic implant impactor, reusable

MEDALLION MODULAR HIP SYSTEM - 00880304640047

No Description
Biomet Orthopedics, LLC
71-007001
In Commercial Distribution

  • 00880304640047 ()

  • 24 MM
71-007001

  • Uncoated hip femur prosthesis, modular

Alexis Wound Protector-Retractor - 00607915117245

Wound Retractor and Protector
APPLIED MEDICAL RESOURCES CORPORATION
C8312
In Commercial Distribution

  • 10607915117242 ()
  • 00607915117245 ()

  • 2-4 cm


  • Radial surgical retractor

Alexis Wound Protector-Retractor - 00607915132958

Wound Retractor and Protector
APPLIED MEDICAL RESOURCES CORPORATION
C8322
In Commercial Distribution

  • 10607915132955 ()
  • 00607915132958 ()

  • 2-4 cm


  • Radial surgical retractor

IMMCO DIAGNOSTICS - 00845714001208

Anti-Neutrophil Cytoplasmic Antibody (ANCA) IFA Kit
IMMCO DIAGNOSTICS, INC.
1116X
In Commercial Distribution

  • 00845714001208 ()

  • 24 determinations
116X

  • Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassay

IMMCO DIAGNOSTICS - 00845714000317

Anti-Neutrophil Cytoplasmic Antibody (ANCA) IFA Kit
IMMCO DIAGNOSTICS, INC.
1116
In Commercial Distribution

  • 00845714000317 ()

  • 24 determinations
1116

  • Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassay

MONOFLUO - 00847865001519

MONOFLUO Pneumocystis jirovecii (P. carinii) IFA Test
Bio-RAD Laboratories, Inc.
32515
In Commercial Distribution

  • 00847865001519 ()

  • 24 Tests
32515

  • Pneumocystis jirovecii antigen IVD, kit, direct fluorescent test (DFT)

Kallestad - 00847865001496

MONOFLUO Legionella pneumophila IFA Test Kit
Bio-RAD Laboratories, Inc.
32514
In Commercial Distribution

  • 00847865001496 ()

  • 24 Tests
32514

  • Legionella pneumophila immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, fluorescent immunoassay

Ascend - 00846832024049

DISTAL SOUNDER
TORNIER, INC.
SH069704
In Commercial Distribution

  • 00846832024049 ()

  • Size 2-4
SH069704

  • Orthopaedic prosthesis implantation positioning instrument, reusable

ACRYSOF® IQ RESTOR® - 00380655101193

AcrySof(R) ReSTOR(R) APODIZED DIFFRACTIVEASPHERIC SINGLE-PIECE IOL, 13.0mm LENGTH,6.0mm OPTIC, PLANAR HAPTICS.
Alcon Laboratories, Inc.
SN6AD3
Not in Commercial Distribution

  • 00380655101193 ()

  • Diopter 24


  • Posterior-chamber intraocular lens, pseudophakic

AcrySof® ACRYSERT® - 00380655097540

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

  • 00380655097540 ()

  • Diopter 24
SN60WS.240

  • Posterior-chamber intraocular lens, pseudophakic

ACRYSOF® Monoflex® - 00380655095195

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

  • 00380655095195 ()

  • Diopter 24
MN60AC.240

  • Posterior-chamber intraocular lens, pseudophakic

ACRYSOF® - 00380655093276

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

  • 00380655093276 ()

  • Diopter 24
SN60WF.240

  • Posterior-chamber intraocular lens, pseudophakic

ACRYSOF® - 00380652555883

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

  • 00380652555883 ()

  • Diopter 24
SA60AT.240

  • Posterior-chamber intraocular lens, pseudophakic

ACRYSOF® Monoflex® - 00380652552608

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

  • 00380652552608 ()

  • Diopter 24
MA60AC.240

  • Posterior-chamber intraocular lens, pseudophakic

ACRYSOF® Monoflex® - 00380652551625

AcrySof(R) SOFT ACRYLIC MULTIPIECE STERILEPCL(IOL/PC), 12.5mm LENGTH, 5.5mm ANTERIORASYMMETRIC BICONVEX OPTIC, Monoflex(TM*)5-DEGREE HAPTICS. *REG. U.S. PAT. & TM OFF.
Alcon Laboratories, Inc.
MA30AC
Not in Commercial Distribution

  • 00380652551625 ()

  • Diopter 24
MA30AC.240

  • Posterior-chamber intraocular lens, pseudophakic

Alcon Single-Piece PMMA - 00380652540834

SINGLE-PIECE PMMA STERILE PCL (IOL/PC),13.5mm LENGTH, 6.0mm BICONVEX OPTIC,10-DEGREE HAPTICS.
Alcon Laboratories, Inc.
TYPE01
Not in Commercial Distribution

  • 00380652540834 ()

  • Diopter 24
TYPE01.240

  • Posterior-chamber intraocular lens, pseudophakic

Alcon Single-Piece PMMA Slant - 00380652538930

SINGLE-PIECE PMMA STERILE PCL (IOL/PC),11.5mm LENGTH, 5.0mm BICONVEX OPTIC,5-DEGREE "SLANT"(TM*) HAPTICS. *REG. U.S. PAT. & TM OFF.
Alcon Laboratories, Inc.
MZ40BD
Not in Commercial Distribution

  • 00380652538930 ()

  • Diopter 24
MZ40BD.240

  • Posterior-chamber intraocular lens, pseudophakic

Multiflex - 00380652536462

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

  • 00380652536462 ()

  • Diopter 24
MTA5U0.240

  • Anterior-chamber intraocular lens, pseudophakic

Multiflex - 00380652535977

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

  • 00380652535977 ()

  • Diopter 24
MTA4U0.240

  • Anterior-chamber intraocular lens, pseudophakic

ACRYSOF® RESTOR® - 00380652307826

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

  • 00380652307826 ()

  • Diopter 24


  • Posterior-chamber intraocular lens, pseudophakic

ACRYSOF® - 00380652279703

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

  • 00380652279703 ()

  • Diopter 24
SN6AT9U240

  • Posterior-chamber intraocular lens, pseudophakic

ACRYSOF® - 00380652278119

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

  • 00380652278119 ()

  • Diopter 24
SN6AT8U240

  • Posterior-chamber intraocular lens, pseudophakic

ACRYSOF® - 00380652276535

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

  • 00380652276535 ()

  • Diopter 24
SN6AT7U240

  • Posterior-chamber intraocular lens, pseudophakic

ACRYSOF® - 00380652332743

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

  • 00380652332743 ()

  • Diopter 24
SA60WF.240

  • Posterior-chamber intraocular lens, pseudophakic

ACRYSOF® - 00380652274944

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

  • 00380652274944 ()

  • Diopter 24
SN6AT6U240

  • Posterior-chamber intraocular lens, pseudophakic

ACRYSOF, IQ RESTOR - 00380652270700

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 2.61
Alcon Laboratories, Inc.
SND1T4
Not in Commercial Distribution

  • 00380652270700 ()

  • Diopter 24
SND1T4U240

  • Posterior-chamber intraocular lens, pseudophakic
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