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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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Disc Prep - 10889981103538

Ring Currette #2, 18"OAL, 9" Handle
Seaspine Orthopedics Corporation
06-40-0352
In Commercial Distribution

  • 10889981103538 ()

  • 18", 9"
06-40-0352

  • Poliovirus total antibody (serotypes PV1-PV3) IVD, kit, complement fixation test (CFT)

OSS - 00880304347755

No Description
Biomet Orthopedics, LLC
32-472684
In Commercial Distribution

  • 00880304347755 ()

  • 9 CM
32-472684

  • Orthopaedic implant/instrument dismantling device

OSS(TM) - 00880304347571

No Description
Biomet Orthopedics, LLC
32-472666
In Commercial Distribution

  • 00880304347571 ()

  • 9 MM
32-472666

  • Medullary canal orthopaedic reamer, rigid

OSS - 00880304347366

No Description
Biomet Orthopedics, LLC
32-472639
In Commercial Distribution

  • 00880304347366 ()

  • 9 MM
32-472639

  • Bone-resection orthopaedic reamer, reusable

GENERATION 4 HIP SYSTEM - 00880304253537

No Description
Biomet Orthopedics, LLC
162781
In Commercial Distribution

  • 00880304253537 ()

  • 9 SIZE
162781

  • Orthopaedic cement spacer

ANSWER / IMPACT / INTEGRAL HIP SYSTEM - 00880304253162

No Description
Biomet Orthopedics, LLC
162656
In Commercial Distribution

  • 00880304253162 ()

  • 9 SIZE
162656

  • Orthopaedic cement spacer

Oxford Uni Knee System - 00880304525412

No Description
Biomet Uk Ltd
32-422804
In Commercial Distribution

  • 00880304525412 ()

  • Size 9
32-422804

  • Abdominal/ENT/orthopaedic surgical probe, reusable

TUNNELOC - 00880304516748

No Description
Biomet Sports Medicine, LLC
906513
In Commercial Distribution

  • 00880304516748 ()

  • 9 MM
906513

  • Tendon/ligament bone anchor, non-bioabsorbable

OSS(TM) - 00880304347182

No Description
Biomet Orthopedics, LLC
32-472096
In Commercial Distribution

  • 00880304347182 ()

  • 9 CM
32-472096

  • Knee femur prosthesis trial, reusable

OSS™ Orthopedic Salvage System - 00880304239883

No Description
Biomet Orthopedics, LLC
150467
In Commercial Distribution

  • 00880304239883 ()

  • 9 CM
150467

  • Diaphysis prosthesis

OSS™ Orthopedic Salvage System - 00880304674929

No Description
Biomet Orthopedics, LLC
151840
In Commercial Distribution

  • 00880304674929 ()

  • 9 CM
151840

  • Diaphysis prosthesis

Cambria - 10889981092931

Cambria Inserter, 9 in
Seaspine Orthopedics Corporation
93-9006
In Commercial Distribution

  • 10889981092931 ()

  • 9 in
93-9006

  • Orthopaedic inorganic implant inserter/extractor, reusable

MAESTRO TOTAL WRIST - 00880304439207

No Description
Biomet Orthopedics, LLC
180153
In Commercial Distribution

  • 00880304439207 ()

  • 9 MM
180153

  • Total wrist radius prosthesis

MAESTRO TOTAL WRIST - 00880304439108

No Description
Biomet Orthopedics, LLC
180152
In Commercial Distribution

  • 00880304439108 ()

  • 9 MM
180152

  • Total wrist radius prosthesis

Klassic Blade Femoral Broach - 00819251020411

Blade Femoral Broach, size 9
TOTAL JOINT ORTHOPEDICS, INC.
1109.09.000
In Commercial Distribution

  • 00819251020411 ()

  • size 9


  • Orthopaedic broach

Klassic HD Modular Femoral Broach - 00819251020305

Modular Femoral Broach, size 9
TOTAL JOINT ORTHOPEDICS, INC.
1106.09.000
In Commercial Distribution

  • 00819251020305 ()

  • size 9


  • Orthopaedic broach

Femoral Broach - 00819251020107

Femoral Broach, Size 9
TOTAL JOINT ORTHOPEDICS, INC.
1100.09.000
In Commercial Distribution

  • 00819251020107 ()

  • Size 9


  • Orthopaedic broach

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

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® - 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, 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® - 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® - 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

INSTRUMENT - 07613327179088

SCORPIO TRIAL CUTTING GUIDE
Howmedica Osteonics Corp.
8200-5009
In Commercial Distribution

  • 07613327179088 ()

  • Size: 9
8200-5009

  • Orthopaedic prosthesis implantation positioning instrument, reusable

Scorpio - 07613327014280

Tibial Augmentation Full Wedge
Howmedica Osteonics Corp.
75-5-0905
In Commercial Distribution

  • 07613327014280 ()

  • Size: 9
  • Angle: 5.0 degree
75-5-0905

  • Knee arthroplasty wedge

Omnifit - 07613327013627

Proximal Cement Spacer
Howmedica Osteonics Corp.
1058-0009
In Commercial Distribution

  • 07613327013627 ()

  • Size: 9
1058-0009

  • Orthopaedic cement spacer

Omniflex - 07613327012712

Smooth Collar Femoral Stem
Howmedica Osteonics Corp.
1022-0009
In Commercial Distribution

  • 07613327012712 ()

  • Size: 9
1022-0009

  • Press-fit femoral stem prosthesis

Z1™ Hip System - 00887868578533

No Description
Zimmer, Inc.
611889090
In Commercial Distribution

  • 00887868578533 ()

  • Size 9
611889090

  • Bone file/rasp, manual, reusable

Z1™ Hip System - 00887868576195

No Description
Zimmer, Inc.
611103090
In Commercial Distribution

  • 00887868576195 ()

  • Size 9
611103090

  • Coated hip femur prosthesis, modular

Z1™ Hip System - 00887868576065

No Description
Zimmer, Inc.
611102090
In Commercial Distribution

  • 00887868576065 ()

  • Size 9
611102090

  • Coated hip femur prosthesis, modular

Z1™ Hip System - 00887868575938

No Description
Zimmer, Inc.
611101090
In Commercial Distribution

  • 00887868575938 ()

  • Size 9
611101090

  • Coated hip femur prosthesis, modular

Z1™ Hip System - 00887868575808

No Description
Zimmer, Inc.
611203090
In Commercial Distribution

  • 00887868575808 ()

  • Size 9
611203090

  • Coated hip femur prosthesis, modular

Z1™ Hip System - 00887868575679

No Description
Zimmer, Inc.
611202090
In Commercial Distribution

  • 00887868575679 ()

  • Size 9
611202090

  • Coated hip femur prosthesis, modular

Z1™ Hip System - 00887868575549

No Description
Zimmer, Inc.
611201090
In Commercial Distribution

  • 00887868575549 ()

  • Size 9
611201090

  • Coated hip femur prosthesis, modular

Impingement Rod - 00887868569210

No Description
Biomet Orthopedics, LLC
909935
In Commercial Distribution

  • 00887868569210 ()

  • 9 mm
909935

  • Surgical depth gauge, reusable

Double Bundle - 00887868568893

No Description
Biomet Orthopedics, LLC
909749
In Commercial Distribution

  • 00887868568893 ()

  • 9 mm
909749

  • Surgical drill guide, reusable

Cannulated Dilator - 00887868568466

No Description
Biomet Orthopedics, LLC
907790
In Commercial Distribution

  • 00887868568466 ()

  • 9 mm
907790

  • Orthopaedic implant driver

OSS™ - 00887868564529

No Description
Biomet Orthopedics, LLC
32-472639
In Commercial Distribution

  • 00887868564529 ()

  • 9 mm
32-472639

  • Bone-resection orthopaedic reamer, reusable
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