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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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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)
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
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
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
DISTAL SOUNDER
TORNIER, INC.
SH069704
In Commercial Distribution

  • 00846832024049 ()

  • Size 2-4
SH069704

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Wound Retractor and Protector
APPLIED MEDICAL RESOURCES CORPORATION
C8322
In Commercial Distribution

  • 10607915132955 ()
  • 00607915132958 ()

  • 2-4 cm


  • Radial surgical retractor
Wound Retractor and Protector
APPLIED MEDICAL RESOURCES CORPORATION
C8312
In Commercial Distribution

  • 10607915117242 ()
  • 00607915117245 ()

  • 2-4 cm


  • Radial surgical retractor
S2S CrossBar, 24 - 29mm. The Sierra occipito-cervico-thoracic (OCT) spinal fixation system, including polyaxial screws, rods, locking caps, occipital plates, occipital screws, lateral connectors, contoured crossbars, hooks, and components, is used to provide stabilization of the spine in order to permit the biological process of spinal fusion to occur. Accepted standard techniques of spinal fusion are an integral part of the implantation of this system.
Seaspine Orthopedics Corporation
50-2021
Not in Commercial Distribution

  • 10889910059141 ()

  • 24 - 29mm
50-2021

  • Vertebral body prosthesis, non-sterile
No Description
Biomet Orthopedics, LLC
423694
In Commercial Distribution

  • 00880304009288 ()

  • 24 MM
423694

  • Orthopaedic inorganic implant inserter/extractor, reusable
No Description
Biomet Orthopedics, LLC
423334
In Commercial Distribution

  • 00880304371156 ()

  • SIZE 24
423334

  • Orthopaedic implant impactor, reusable
No Description
Biomet Orthopedics, LLC
11-302124
In Commercial Distribution

  • 00880304474352 ()

  • 24 MM
11-302124

  • Coated femoral stem prosthesis, modular
No Description
Biomet Orthopedics, LLC
178566
In Commercial Distribution

  • 00880304461642 ()

  • 24 MM
178566

  • Knee femur stem prosthesis
No Description
Biomet Orthopedics, LLC
106024
In Commercial Distribution

  • 00880304455078 ()

  • 24 SIZE
106024

  • Acetabular shell
No Description
Biomet Orthopedics, LLC
31-300574
In Commercial Distribution

  • 00880304496873 ()

  • SIZE 24
31-300574

  • Bone-resection orthopaedic reamer, reusable
No Description
Biomet Orthopedics, LLC
24524
In Commercial Distribution

  • 00880304492530 ()

  • 24 MM
24524

  • Orthopaedic bone screw, non-bioabsorbable, sterile
No Description
Biomet Orthopedics, LLC
71-007001
In Commercial Distribution

  • 00880304640047 ()

  • 24 MM
71-007001

  • Uncoated hip femur prosthesis, modular
No Description
Biomet Orthopedics, LLC
105424
In Commercial Distribution

  • 00880304191655 ()

  • 24 SIZE
105424

  • Acetabular shell
No Description
Biomet Orthopedics, LLC
110005138
In Commercial Distribution

  • 00880304567863 ()

  • SIZE 24
110005138

  • Orthopaedic implant impactor, reusable
GenetiSure Dx Hybridization Kit
AGILENT TECHNOLOGIES, INC.
K1201-64200
In Commercial Distribution

  • 05700571112625 ()

  • 24 tests


  • Intellectual/developmental disability genotyping IVD, kit, nucleic acid technique (NAT)
GenetiSure Dx Labeling Kit Purification Columns
AGILENT TECHNOLOGIES, INC.
K1201-64110
In Commercial Distribution

  • 05700571112618 ()

  • 24 tests


  • Intellectual/developmental disability genotyping IVD, kit, nucleic acid technique (NAT)
GenetiSure Dx Labeling Kit
AGILENT TECHNOLOGIES, INC.
K1201-64105
In Commercial Distribution

  • 05700571112601 ()

  • 24 tests


  • Intellectual/developmental disability genotyping IVD, kit, nucleic acid technique (NAT)
GenetiSure Dx Postnatal Assay
AGILENT TECHNOLOGIES, INC.
K1201A
In Commercial Distribution

  • 05700571108697 ()

  • 24 tests


  • Intellectual/developmental disability genotyping IVD, kit, nucleic acid technique (NAT)
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

  • 00380652263139 ()

  • Diopter 24


  • Posterior-chamber intraocular lens, pseudophakic
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

  • 00380652250504 ()

  • Diopter 24
SN6AT4.240

  • Posterior-chamber intraocular lens, pseudophakic
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

  • 00380652249294 ()

  • Diopter 24
SN6CWS.240

  • Posterior-chamber intraocular lens, pseudophakic
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(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
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
SINGLE-PIECE PMMA STERILE PCL (IOL/PC),12.0mm LENGTH, 5.5mm BICONVEX OPTIC,5-DEGREE "SLANT"(TM*) HAPTICS. *REG. U.S. PAT. & TM OFF.
Alcon Laboratories, Inc.
MZ30BD
Not in Commercial Distribution

  • 00380650702173 ()

  • Diopter 24
MZ30BD.240

  • Posterior-chamber intraocular lens, pseudophakic
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

  • 00380650701367 ()

  • Diopter 24
MTA3U0.240

  • Anterior-chamber intraocular lens, pseudophakic
SINGLE-PIECE PMMA STERILE PCL (IOL/PC),13.5mm LENGTH, 6.5mm BICONVEX OPTIC,5-DEGREE "SLANT"(TM*) HAPTICS. *REG. U.S. PAT. & TM OFF.
Alcon Laboratories, Inc.
MC50BD
Not in Commercial Distribution

  • 00380650700032 ()

  • Diopter 24
MC50BD.240

  • Posterior-chamber intraocular lens, pseudophakic
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

  • 00380650698612 ()

  • Diopter 24
MA50BM.240

  • Posterior-chamber intraocular lens, pseudophakic
"SLIMPLANT"(TM*) SINGLE-PIECE PMMA STERILE PCL(IOL/PC), 12.0mm LENGTH, 5.25mm BICONVEXOPTIC, 5-DEGREE "SLANT"(TM*) HAPTICS. *REG. U.S. PAT. & TM OFF.
Alcon Laboratories, Inc.
LX10BD
Not in Commercial Distribution

  • 00380650697349 ()

  • Diopter 24
LX10BD.240

  • Posterior-chamber intraocular lens, pseudophakic
SINGLE-PIECE PMMA STERILE PCL (IOL/PC),12.5mm LENGTH, 7.0mm BICONVEX OPTIC,5-DEGREE "SLANT"(TM*) HAPTICS WITH EYELETS. *REG. U.S. PAT. & TM OFF.
Alcon Laboratories, Inc.
CZ70BD
In Commercial Distribution

  • 00380650696601 ()

  • Diopter 24
CZ70BD.240

  • Posterior-chamber intraocular lens, pseudophakic
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

  • 00380650130389 ()

  • Diopter 24
SN60AT.240

  • Posterior-chamber intraocular lens, pseudophakic
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

  • 00380652251075 ()

  • Diopter 24
SN6AT5.240

  • Posterior-chamber intraocular lens, pseudophakic
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

  • 00380652249973 ()

  • Diopter 24
SN6AT3.240

  • Posterior-chamber intraocular lens, pseudophakic
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(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(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
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