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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(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(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
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(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™*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(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(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
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
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
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
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
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
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
DISTAL SOUNDER
TORNIER, INC.
SH069704
In Commercial Distribution

  • 00846832024049 ()

  • Size 2-4
SH069704

  • Orthopaedic prosthesis implantation positioning instrument, reusable
No Description
Biomet Uk Ltd
31-400624
In Commercial Distribution

  • 05019279415328 ()

  • SIZE 24
31-400624

  • Orthopaedic implant impactor, reusable
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

  • 00380652358354 ()

  • Diopter 24
AU00T0.240

  • 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
A non-sterile head covering designed as a cap intended to be worn by surgical staff during an operation to protect both the patient and themselves from the transfer of microorganisms, body fluids, and particulate material. It is usually made of reinforced paper or non-woven materials. This is a single-use device.
FORSURE MEDICAL PRODUCTS LLC
16300024
In Commercial Distribution

  • 00897633001654 ()
  • 20897633001658 ()

  • 24" Blue
16300024

  • Surgical cap, single-use
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