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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
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
Rebuilt no-slip tip urethral suture guide
GRACE MANUFACTURING, INC.
58954-24
In Commercial Distribution

  • 10801334013486 ()

  • 24 French
U515R

  • Suturing needle, reusable
Urethral suture guide
GRACE MANUFACTURING, INC.
58900-24
In Commercial Distribution

  • 10801334012595 ()

  • 24 French
U501

  • Suturing needle, reusable
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